May 26, 2011
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
Drug Shortages: Current Drug Shortages: Norepinephrine Bitartrate Injection (updated)
ANDA Checklist for Completeness and Acceptability (PDF - 159KB) (updated)
CDER Key Officials List (PDF - 114KB) (Updated)
Drug Firm Annual Registration Status (updated)
Drugs@FDA Download File (updated)
FDA Statement on the AIM-HIGH Trial
FDA/DDMAC Issue Letter to Noven Pharmaceuticals for Pexeva (PDF - 45KB)
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
May 26, 2011
Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Approval
Risperidone Oral Solution, Amneal Pharmaceuticals, Approval
Tenofovir Disoproxil Fumarate Tablets, Strides Inc., Tentative Approval
Warfarin Sodium Tablets, Invagen Pharmaceuticals, Inc., Approval
lunes, 30 de mayo de 2011
What's New on the FDA Drugs Site
May 26, 2011
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
Drug Shortages: Current Drug Shortages: Norepinephrine Bitartrate Injection (updated)
ANDA Checklist for Completeness and Acceptability (PDF - 159KB) (updated)
CDER Key Officials List (PDF - 114KB) (Updated)
Drug Firm Annual Registration Status (updated)
Drugs@FDA Download File (updated)
FDA Statement on the AIM-HIGH Trial
FDA/DDMAC Issue Letter to Noven Pharmaceuticals for Pexeva (PDF - 45KB)
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
May 26, 2011
Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Approval
Risperidone Oral Solution, Amneal Pharmaceuticals, Approval
Tenofovir Disoproxil Fumarate Tablets, Strides Inc., Tentative Approval
Warfarin Sodium Tablets, Invagen Pharmaceuticals, Inc., Approval
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
Drug Shortages: Current Drug Shortages: Norepinephrine Bitartrate Injection (updated)
ANDA Checklist for Completeness and Acceptability (PDF - 159KB) (updated)
CDER Key Officials List (PDF - 114KB) (Updated)
Drug Firm Annual Registration Status (updated)
Drugs@FDA Download File (updated)
FDA Statement on the AIM-HIGH Trial
FDA/DDMAC Issue Letter to Noven Pharmaceuticals for Pexeva (PDF - 45KB)
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
May 26, 2011
Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Approval
Risperidone Oral Solution, Amneal Pharmaceuticals, Approval
Tenofovir Disoproxil Fumarate Tablets, Strides Inc., Tentative Approval
Warfarin Sodium Tablets, Invagen Pharmaceuticals, Inc., Approval
jueves, 26 de mayo de 2011
What's New on the FDA Drugs Site
May 23, 2011
Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
Drug Shortages: Resolved Drug Shortages: BICNU (Carmustine) Injection, 100 mg (NDC 00015-3012-60)
Drug Shortages: Resolved Drug Shortages: Renacidin Irrigation NDC 00327-0011-05
FDA approves Incivek (telaprevir)for hepatitic C
Table of Pharmacogenomic Biomarkers in Drug Labels (updated)
New and Generic Drug Approvals
May 23, 2011
Incivek (telaprevir) Tablets, Vertex Pharmaceuticals, Inc., Approval
Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
Drug Shortages: Resolved Drug Shortages: BICNU (Carmustine) Injection, 100 mg (NDC 00015-3012-60)
Drug Shortages: Resolved Drug Shortages: Renacidin Irrigation NDC 00327-0011-05
FDA approves Incivek (telaprevir)for hepatitic C
Table of Pharmacogenomic Biomarkers in Drug Labels (updated)
New and Generic Drug Approvals
May 23, 2011
Incivek (telaprevir) Tablets, Vertex Pharmaceuticals, Inc., Approval
FDA MedWATCH
Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall - Incorrect Electrolyte Results
AUDIENCE: Laboratory, Risk Manager
ISSUE: Healthcare professionals were notified that there may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect electrolyte results. This may cause serious adverse health consequences or death.
BACKGROUND: These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including blood, urine, and cerebrospinal fluid.
RECOMMENDATION: On April 5, 2011, the company sent its customers a Product Corrective Action letter including a customer response form. The company requested customers to follow the new maintenance instructions included in the letter.
Based on the available information at this time, it appears that the root cause may be a maintenance-related issue. However, the root cause has not been definitively determined and it is recommended that the laboratories maintain a level of vigilance to assess whether the change in maintenance routine resolves the issue.
Healthcare professionals are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
AUDIENCE: Laboratory, Risk Manager
ISSUE: Healthcare professionals were notified that there may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect electrolyte results. This may cause serious adverse health consequences or death.
BACKGROUND: These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including blood, urine, and cerebrospinal fluid.
RECOMMENDATION: On April 5, 2011, the company sent its customers a Product Corrective Action letter including a customer response form. The company requested customers to follow the new maintenance instructions included in the letter.
Based on the available information at this time, it appears that the root cause may be a maintenance-related issue. However, the root cause has not been definitively determined and it is recommended that the laboratories maintain a level of vigilance to assess whether the change in maintenance routine resolves the issue.
Healthcare professionals are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
FDA MEDWATCH
Pentrexyl Forte Natural: Recall - Misleading Packaging
AUDIENCE: Consumer, Pharmacy
ISSUE: Phoenix Import & Distribution LLC and FDA notified the public of a recall for Pentrexyl Forte Natural because the packaging is believed to be misleading, causing it to be confused with an antibiotic. Pentrexyl Forte Natural is a Dietary Supplement only and does not contain antibiotics. Use of the product by ill individuals could delay treatment for serious illnesses.
BACKGROUND: The product is packaged in a green and white box, containing 30 red and white capsules. The product was sold through retail stores in Texas.
RECOMMENDATION: Consumers who have purchased the product can return it to the place where it was purchased.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
AUDIENCE: Consumer, Pharmacy
ISSUE: Phoenix Import & Distribution LLC and FDA notified the public of a recall for Pentrexyl Forte Natural because the packaging is believed to be misleading, causing it to be confused with an antibiotic. Pentrexyl Forte Natural is a Dietary Supplement only and does not contain antibiotics. Use of the product by ill individuals could delay treatment for serious illnesses.
BACKGROUND: The product is packaged in a green and white box, containing 30 red and white capsules. The product was sold through retail stores in Texas.
RECOMMENDATION: Consumers who have purchased the product can return it to the place where it was purchased.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
EDQM News - May 2011
World Blood Donor Day – Celebrating the gift of blood
World Blood Donor Day is celebrated on 14th June every year. The theme for this year is "More Blood. More Life". For more information on this Day and on events, visit: http://www.edqm.eu/en/World-Blood-Donor-Day-1381.html
European Pharmacopoeia
Decisions taken at the 139th Session of the PhEur Commission: http://www.edqm.eu/en/News-and-General-Information-43.html
Enquiry: Demonstration of Uniformity of Dosage Units using Large Sample Sizes (Deadline: 30 June 2011)
Proposal for a new general chapter in the European Pharmacopoeia. More information: http://www.edqm.eu/en/News-and-General-Information-43.html
Certification
Monthly Report of Activities (April 2011): http://www.edqm.eu/en/News-and-General-Information-164.html
Policy document revised - Suspension or withdrawal of a CEP : http://www.edqm.eu/en/News-and-General-Information-164.html
Note concerning CEPs for gelatin & impact of the revised EU Note for Guidance on TSE risk: http://www.edqm.eu/en/News-and-General-Information-164.html
HealthCare - Classification of Medicines as Regards their Supply
Evidence-based classification reviews 2007-2010 available : http://www.edqm.eu/en/page_1241.php
Publications
Blood Transfusion Guide
NEW EDITION: Guide to the preparation, use and quality assurance of blood components, 16th Edition (2010) now available to order. More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
Organ Transplantation Guide
NEW EDITION: Guide to the safety and quality assurance for the transplantation of organs, tissues and cells, 4th Edition (2010) now available to order. More information:
http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
NEW: Pharmeuropa Bio & Scientific Notes 2011-1 (June 2011)
List of Contents now available. For more information on how to order : www.edqm.eu/store/
Instructions for Authors has been updated: http://www.edqm.eu/en/Pharmeuropa-Pharmeuropa-Bio-amp-Scientific-Notes-584.html
7th Edition European Pharmacopoeia 2012
We are currently taking orders online for the 7th Edition 2012 (Supplement 7.3 to 7.5). For more information: www.edqm.eu/store
Technical Guides
Recommendations for the layout of monographs on substances of human and animal origin: http://www.edqm.eu/en/Technical-Guides-589.html
Employment
Vacancy Notice N° e105/2011: Fixed-term contract: Production/Distribution Operator (Grade C1/C2)
Reference Standards and Samples Division. Closing Date: 27 May 2011. More information: http://www.edqm.eu/en/Employment-1377.html
Events
Meet the EDQM at the 21st Regional Congress of the ISBT, 18-22 June 2011, Lisbon, Portugal: http://www.edqm.eu/en/Fairs-Exhibitions-254.html
Book today your ‘One-to-One Session’ with the EDQM Certification Division at CPhI China, 21-23 June 2011, Shanghai, China: http://www.edqm.eu/en/Fairs-Exhibitions-254.html
Places still available - 7th Edition European Pharmacopoeia Training Session, 11-12 July 2011, Strasbourg, France. Open for registrations : http://www.edqm.eu/en/PhEur-Training-Session-Strasbourg-France-256.html
Symposium on ‘Alternatives to Animal Testing’, 8-9 September 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/EDQM-Symposium-Alternatives-to-Animal-Testing-1374.html
Other interesting events supported by the EDQM:
7-8 June 2011: 2011 PDA Europe Workshop on Advanced Therapy Medicinal Products in Collaboration with the Finnish Medicines Agency (Fimea)
Helsinki, Finland. More information: http://www.edqm.eu/en/Events-253.html
APIB Event ‘Active Pharmaceutical Ingredients from Biotechnology: from research to industrial and regulatory issues’, 14-17 June 2011, Madrid, Spain.
More information: http://www.edqm.eu/en/APIB-2011-Madrid-Spain-14-17-June-2011-1405.html
World Blood Donor Day is celebrated on 14th June every year. The theme for this year is "More Blood. More Life". For more information on this Day and on events, visit: http://www.edqm.eu/en/World-Blood-Donor-Day-1381.html
European Pharmacopoeia
Decisions taken at the 139th Session of the PhEur Commission: http://www.edqm.eu/en/News-and-General-Information-43.html
Enquiry: Demonstration of Uniformity of Dosage Units using Large Sample Sizes (Deadline: 30 June 2011)
Proposal for a new general chapter in the European Pharmacopoeia. More information: http://www.edqm.eu/en/News-and-General-Information-43.html
Certification
Monthly Report of Activities (April 2011): http://www.edqm.eu/en/News-and-General-Information-164.html
Policy document revised - Suspension or withdrawal of a CEP : http://www.edqm.eu/en/News-and-General-Information-164.html
Note concerning CEPs for gelatin & impact of the revised EU Note for Guidance on TSE risk: http://www.edqm.eu/en/News-and-General-Information-164.html
HealthCare - Classification of Medicines as Regards their Supply
Evidence-based classification reviews 2007-2010 available : http://www.edqm.eu/en/page_1241.php
Publications
Blood Transfusion Guide
NEW EDITION: Guide to the preparation, use and quality assurance of blood components, 16th Edition (2010) now available to order. More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
Organ Transplantation Guide
NEW EDITION: Guide to the safety and quality assurance for the transplantation of organs, tissues and cells, 4th Edition (2010) now available to order. More information:
http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
NEW: Pharmeuropa Bio & Scientific Notes 2011-1 (June 2011)
List of Contents now available. For more information on how to order : www.edqm.eu/store/
Instructions for Authors has been updated: http://www.edqm.eu/en/Pharmeuropa-Pharmeuropa-Bio-amp-Scientific-Notes-584.html
7th Edition European Pharmacopoeia 2012
We are currently taking orders online for the 7th Edition 2012 (Supplement 7.3 to 7.5). For more information: www.edqm.eu/store
Technical Guides
Recommendations for the layout of monographs on substances of human and animal origin: http://www.edqm.eu/en/Technical-Guides-589.html
Employment
Vacancy Notice N° e105/2011: Fixed-term contract: Production/Distribution Operator (Grade C1/C2)
Reference Standards and Samples Division. Closing Date: 27 May 2011. More information: http://www.edqm.eu/en/Employment-1377.html
Events
Meet the EDQM at the 21st Regional Congress of the ISBT, 18-22 June 2011, Lisbon, Portugal: http://www.edqm.eu/en/Fairs-Exhibitions-254.html
Book today your ‘One-to-One Session’ with the EDQM Certification Division at CPhI China, 21-23 June 2011, Shanghai, China: http://www.edqm.eu/en/Fairs-Exhibitions-254.html
Places still available - 7th Edition European Pharmacopoeia Training Session, 11-12 July 2011, Strasbourg, France. Open for registrations : http://www.edqm.eu/en/PhEur-Training-Session-Strasbourg-France-256.html
Symposium on ‘Alternatives to Animal Testing’, 8-9 September 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/EDQM-Symposium-Alternatives-to-Animal-Testing-1374.html
Other interesting events supported by the EDQM:
7-8 June 2011: 2011 PDA Europe Workshop on Advanced Therapy Medicinal Products in Collaboration with the Finnish Medicines Agency (Fimea)
Helsinki, Finland. More information: http://www.edqm.eu/en/Events-253.html
APIB Event ‘Active Pharmaceutical Ingredients from Biotechnology: from research to industrial and regulatory issues’, 14-17 June 2011, Madrid, Spain.
More information: http://www.edqm.eu/en/APIB-2011-Madrid-Spain-14-17-June-2011-1405.html
What's New on the FDA Drugs Site
May 20, 2011
FDA approves new HIV treatment
FDA approves Sutent (sunitinib) for rare type of pancreatic cancer
FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
New and Generic Drug Approvals
May 20, 2011
Aldactazide (spironolactone and hydrochlorothiazide) Tablets, Pfizer, Inc., Labeling Revision
Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Labeling Revision
Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision
Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Kwikpen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Pen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Teveten HCT (eprosartan mesylate and hydrochlorothiazide) Tablets, Abbott Laboratories, Labeling Revision
Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, UCB, Inc., Labeling Revision
Victoza (liraglutide [rDNA origin]) Subcutaneous Solution, Novo Nordisk, Inc., Labeling Revision
FDA approves new HIV treatment
FDA approves Sutent (sunitinib) for rare type of pancreatic cancer
FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
New and Generic Drug Approvals
May 20, 2011
Aldactazide (spironolactone and hydrochlorothiazide) Tablets, Pfizer, Inc., Labeling Revision
Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Labeling Revision
Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision
Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Kwikpen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Pen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Teveten HCT (eprosartan mesylate and hydrochlorothiazide) Tablets, Abbott Laboratories, Labeling Revision
Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, UCB, Inc., Labeling Revision
Victoza (liraglutide [rDNA origin]) Subcutaneous Solution, Novo Nordisk, Inc., Labeling Revision
lunes, 23 de mayo de 2011
What is new in FDA
May 19, 2011
Chantix: Quarterwatch Article
Drug Shortages: Current Drug Shortages: Acetylcysteine inhalation solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium molybdate injection
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Pentosan Polysulfate sodium 100mg capsules
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% (updated)
New and Generic Drug Approvals
May 19, 2011
Faslodex (fulvestrant) Injection, AstraZeneca Pharmaceuticals LP, Efficacy Supplement
Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceuticals Corp., Labeling Revision
Gemcitabine Injection, APP Pharmaceuticals, LLC, Approval
Genotropin (somatropin [rDNA origin]) Injection, Pfizer, Inc., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Potassium Chloride Extended-Release Capsules, Paddock Laboratories, Inc., Approval
Pravachol (pravastatin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Vagifem (estradiol) Vaginal Tablets, Novo Nordisk Pharmaceuticals, Inc., Labeling Revision
Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision
Chantix: Quarterwatch Article
Drug Shortages: Current Drug Shortages: Acetylcysteine inhalation solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium molybdate injection
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Pentosan Polysulfate sodium 100mg capsules
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% (updated)
New and Generic Drug Approvals
May 19, 2011
Faslodex (fulvestrant) Injection, AstraZeneca Pharmaceuticals LP, Efficacy Supplement
Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceuticals Corp., Labeling Revision
Gemcitabine Injection, APP Pharmaceuticals, LLC, Approval
Genotropin (somatropin [rDNA origin]) Injection, Pfizer, Inc., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Potassium Chloride Extended-Release Capsules, Paddock Laboratories, Inc., Approval
Pravachol (pravastatin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Vagifem (estradiol) Vaginal Tablets, Novo Nordisk Pharmaceuticals, Inc., Labeling Revision
Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision
SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition
AUDIENCE: Consumers, Pediatrics, Emergency medicine
ISSUE: FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
BACKGROUND: FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula. Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants. SimplyThick was added to the feeding regimen of those infants, who later developed NEC, to help with swallowing difficulties stemming from complications of premature birth.
The product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.
RECOMMENDATION: Health care providers should stop administering the product to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider. See the photographs at the link below for images of the product.
Read the MedWatch safety alert, including links to the Press Release and product photos, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm
Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=05_20_2011_1800&cpp[type]=S
ISSUE: FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
BACKGROUND: FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula. Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants. SimplyThick was added to the feeding regimen of those infants, who later developed NEC, to help with swallowing difficulties stemming from complications of premature birth.
The product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.
RECOMMENDATION: Health care providers should stop administering the product to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider. See the photographs at the link below for images of the product.
Read the MedWatch safety alert, including links to the Press Release and product photos, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm
Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=05_20_2011_1800&cpp[type]=S
miércoles, 18 de mayo de 2011
What is new in FDA
May 17, 2011
Drug Information Widgets: Acetaminophen Information for Consumers and Professionals
Medication Guides (updated)
Drug Information Widgets: Acetaminophen Information for Consumers and Professionals
Medication Guides (updated)
What is new in FDA
May 16, 2011
CDER Forum for International Drug Regulatory Authorities, October 17-21, 2011, College Park, MD. Meeting information
Drug Firm Annual Registration Status (updated)
National Drug Code Directory Search (updated)
National Drug Code Directory Download (updated)
Prescription Drug User Fee Act (PDUFA) Meetings:
FDA-Industry Meeting Minutes, February 24, 2011 (PDF - 66KB)
FDA-Industry Meeting Minutes, February 10, 2011 (PDF - 65KB)
FDA-Industry Meeting Minutes, January 31, 2011 (PDF - 64KB)
New and Generic Drug Approvals
May 16, 2011
Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision
Irinotecan Hydrochloride Injection, Bioniche Pharma USA LLC., Approval
Janumet (sitagliptin phosphate and metformin hydrochloride) Tablets, Merck Sharp and Dohme Corp., Labeling Revision
Levocetirizine Dihydrochloride Oral Solution, Synthon Pharmaceuticals, Inc., Tentative Approval
Mirapex (pramipexole dihydrochloride) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Efficacy Supplement
Sodium Polystyrene Sulfonate Suspension, Paddock Laboratories, Inc., Approval
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision
Ziagen (abacavir sulfate) Tablets, GlaxoSmithKline, Labeling Revision
Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision
CDER Forum for International Drug Regulatory Authorities, October 17-21, 2011, College Park, MD. Meeting information
Drug Firm Annual Registration Status (updated)
National Drug Code Directory Search (updated)
National Drug Code Directory Download (updated)
Prescription Drug User Fee Act (PDUFA) Meetings:
FDA-Industry Meeting Minutes, February 24, 2011 (PDF - 66KB)
FDA-Industry Meeting Minutes, February 10, 2011 (PDF - 65KB)
FDA-Industry Meeting Minutes, January 31, 2011 (PDF - 64KB)
New and Generic Drug Approvals
May 16, 2011
Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision
Irinotecan Hydrochloride Injection, Bioniche Pharma USA LLC., Approval
Janumet (sitagliptin phosphate and metformin hydrochloride) Tablets, Merck Sharp and Dohme Corp., Labeling Revision
Levocetirizine Dihydrochloride Oral Solution, Synthon Pharmaceuticals, Inc., Tentative Approval
Mirapex (pramipexole dihydrochloride) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Efficacy Supplement
Sodium Polystyrene Sulfonate Suspension, Paddock Laboratories, Inc., Approval
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision
Ziagen (abacavir sulfate) Tablets, GlaxoSmithKline, Labeling Revision
Ziagen (abacavir sulfate) Oral Solution, GlaxoSmithKline, Labeling Revision
lunes, 16 de mayo de 2011
ANMAT: SEMINARIO INTERNACIONAL DE PUBLICIDAD
Entre los días 5 y 6 de mayo, se realizó en Buenos Aires el Seminario Internacional
de Publicidad de Medicamentos y Alimentos: el contenido del mensaje, que fue
organizado por el Ministerio de Salud de la Nación, a través de la ANMAT y contó
con el apoyo de la Organización Panamericana de la Salud (OPS). La Sociedad
Argentina de Farmacia y Bioquímica Industrial (SAFYBI) colaboró eficazmente en
algunos aspectos administrativos de la organización.
El seminario contó con la participación de las agencias regulatorias de Argentina,
Brasil, Canadá, Chile, Colombia, España, Francia y México.
En las mesas de presentación se debatieron los siguientes temas:
El contenido de los mensajes en la publicidad de medicamentos de
venta libre: las agencias concluyeron que es de importancia relevante que
la población reciba un mensaje claro y veraz acerca de las características del
medicamento publicitado, con la finalidad de contribuir a que el usuario
tome decisiones racionales, teniendo presente que la exageración en sus
efectos induce a su uso indebido. También se comprometieron a mantener
abierto el diálogo para avanzar en la discusión de los criterios aplicables a
este tipo de mensajes publicitarios, sin por ello afectar los procedimientos
administrativos vigentes en cada país.
Escenario de la promoción de los medicamentos de venta bajo receta
y su uso racional: para la correcta interpretación de los mensajes
promocionales, los disertantes coincidieron en la necesidad de fortalecer la
capacitación a los profesionales de la salud, a fin de lograr la mejor
prescripción y dispensación del medicamento. Resaltaron que el cuerpo
profesional es tan vulnerable a los mensajes promocionales como la
población frente a la publicidad. De las disertaciones y discusiones surgió
que la fiscalización de este segmento no está desarrollada por igual en todos
los países, y que deben realizarse esfuerzos para alcanzar una acción acorde
con la importancia del tema.La publicidad de los alimentos con “propiedades saludables” y su
impacto en los hábitos de consumo: las agencias se focalizaron en el
reconocimiento de las evidencias científicas para fundamentar la promoción
de las características saludables de los productos publicitados. Todas
coincidieron en que un alimento no puede promocionar propiedades
inherentes a medicamentos.
La publicidad de alimentos en general y suplementos dietarios: los
representantes resaltaron la proliferación de publicidades de productos
“mágicos”, con supuestos resultados inmediatos y que exceden a la función
de los suplementos dietarios y/o alimenticios.
Por otra parte las agencias coincidieron, en forma unánime, en armonizar una
estrategia para la fiscalización adecuada en Internet y las redes sociales donde se
promocionan y comercializan productos de calidad y origen dudoso.
Asimismo, se acordó que las agencias regulatorias, además de su función sanitaria,
comiencen a ejercer una actividad pedagógica con el fin de formar profesionales de
la salud y usuarios responsables, para lograr una cultura sanitaria que proteja a la
sociedad.
de Publicidad de Medicamentos y Alimentos: el contenido del mensaje, que fue
organizado por el Ministerio de Salud de la Nación, a través de la ANMAT y contó
con el apoyo de la Organización Panamericana de la Salud (OPS). La Sociedad
Argentina de Farmacia y Bioquímica Industrial (SAFYBI) colaboró eficazmente en
algunos aspectos administrativos de la organización.
El seminario contó con la participación de las agencias regulatorias de Argentina,
Brasil, Canadá, Chile, Colombia, España, Francia y México.
En las mesas de presentación se debatieron los siguientes temas:
El contenido de los mensajes en la publicidad de medicamentos de
venta libre: las agencias concluyeron que es de importancia relevante que
la población reciba un mensaje claro y veraz acerca de las características del
medicamento publicitado, con la finalidad de contribuir a que el usuario
tome decisiones racionales, teniendo presente que la exageración en sus
efectos induce a su uso indebido. También se comprometieron a mantener
abierto el diálogo para avanzar en la discusión de los criterios aplicables a
este tipo de mensajes publicitarios, sin por ello afectar los procedimientos
administrativos vigentes en cada país.
Escenario de la promoción de los medicamentos de venta bajo receta
y su uso racional: para la correcta interpretación de los mensajes
promocionales, los disertantes coincidieron en la necesidad de fortalecer la
capacitación a los profesionales de la salud, a fin de lograr la mejor
prescripción y dispensación del medicamento. Resaltaron que el cuerpo
profesional es tan vulnerable a los mensajes promocionales como la
población frente a la publicidad. De las disertaciones y discusiones surgió
que la fiscalización de este segmento no está desarrollada por igual en todos
los países, y que deben realizarse esfuerzos para alcanzar una acción acorde
con la importancia del tema.La publicidad de los alimentos con “propiedades saludables” y su
impacto en los hábitos de consumo: las agencias se focalizaron en el
reconocimiento de las evidencias científicas para fundamentar la promoción
de las características saludables de los productos publicitados. Todas
coincidieron en que un alimento no puede promocionar propiedades
inherentes a medicamentos.
La publicidad de alimentos en general y suplementos dietarios: los
representantes resaltaron la proliferación de publicidades de productos
“mágicos”, con supuestos resultados inmediatos y que exceden a la función
de los suplementos dietarios y/o alimenticios.
Por otra parte las agencias coincidieron, en forma unánime, en armonizar una
estrategia para la fiscalización adecuada en Internet y las redes sociales donde se
promocionan y comercializan productos de calidad y origen dudoso.
Asimismo, se acordó que las agencias regulatorias, además de su función sanitaria,
comiencen a ejercer una actividad pedagógica con el fin de formar profesionales de
la salud y usuarios responsables, para lograr una cultura sanitaria que proteja a la
sociedad.
What's New on the FDA Drugs Site
May 13, 2011
Drug Shortages: Current Drug Shortages: Thiotepa for Injection (updated)
FDA Approves Victrelis (boceprevir) to Treat Certain Adults with Chronic Hepatitis C
Orange Book: Additions/Deletions for Prescription and OTC Drug Product Lists
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Search
Orange Book: Cumulative Supplement (PDF - 1020KB)
Orange Book: Query Data Files
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
May 13, 2011
Abacavir Sulfate and Lamivudine Oral Suspension Tablets, Cipla, Ltd., Tentative Approval
CeeNU (lomustine) Capsules, Bristol Myers Squibb Co., Labeling Revision
Cutivate (fluticasone propionate) Lotion, Nycomed U.S., Inc., Labeling Revision
Iosat (potassium iodide) Tablets, Anbex, Inc., Chemistry New Strength
Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc., Labeling Revision
Lexapro (escitalopram oxalate) Oral Solution, Forest Laboratories, Inc., Labeling Revision
Nitrofurantoin Oral Suspension, Amneal Pharmaceuticals, Approval
Octreotide Acetate (Preservative Free) Injection, Wockhardt, Ltd., Approval
Oleptro (trazodone hydrochloride) Extended-Release Tablets, Angelini Labopharm Limited Partnership, Labeling Revision
Orsythia (levonorgestrel and ethinyl estradiol) Tablets, Vintage Pharmaceuticals, Approval
Vibramycin (doxycycline) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
Vibramycin (doxycycline calcium) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
Vibramycin (doxycycline hyclate) Capsules, Pfizer Global Research and Development, Labeling Revision
Vibra-Tabs (doxycycline hyclate) Tablets, Pfizer Global Research and Development, Labeling Revision
Victrelis (boceprevir) Capsules, Schering Corp, Approval
Drug Shortages: Current Drug Shortages: Thiotepa for Injection (updated)
FDA Approves Victrelis (boceprevir) to Treat Certain Adults with Chronic Hepatitis C
Orange Book: Additions/Deletions for Prescription and OTC Drug Product Lists
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations Search
Orange Book: Cumulative Supplement (PDF - 1020KB)
Orange Book: Query Data Files
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
May 13, 2011
Abacavir Sulfate and Lamivudine Oral Suspension Tablets, Cipla, Ltd., Tentative Approval
CeeNU (lomustine) Capsules, Bristol Myers Squibb Co., Labeling Revision
Cutivate (fluticasone propionate) Lotion, Nycomed U.S., Inc., Labeling Revision
Iosat (potassium iodide) Tablets, Anbex, Inc., Chemistry New Strength
Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc., Labeling Revision
Lexapro (escitalopram oxalate) Oral Solution, Forest Laboratories, Inc., Labeling Revision
Nitrofurantoin Oral Suspension, Amneal Pharmaceuticals, Approval
Octreotide Acetate (Preservative Free) Injection, Wockhardt, Ltd., Approval
Oleptro (trazodone hydrochloride) Extended-Release Tablets, Angelini Labopharm Limited Partnership, Labeling Revision
Orsythia (levonorgestrel and ethinyl estradiol) Tablets, Vintage Pharmaceuticals, Approval
Vibramycin (doxycycline) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
Vibramycin (doxycycline calcium) Oral Suspension, Pfizer Global Research and Development, Labeling Revision
Vibramycin (doxycycline hyclate) Capsules, Pfizer Global Research and Development, Labeling Revision
Vibra-Tabs (doxycycline hyclate) Tablets, Pfizer Global Research and Development, Labeling Revision
Victrelis (boceprevir) Capsules, Schering Corp, Approval
What's New on the FDA Drugs Site
May 12, 2011
Drug Shortages: Current Drug Shortages: Calcitriol 1 mcg/mL Injection
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
FDA Issues Warning Letters to Teva Pharmaceutical Industries and Moehs Cantabra for CGMP violations
Postmarketing Drug Safety Evaluations (updated)
New and Generic Drug Approvals
May 12, 2011
Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Sandoz, Inc., Tentative Approval
Bromfenac Sodium Ophthalmic Solution, Coastal Pharmaceuticals, Approval
Dexamethasone Elixir, Vintage Pharmaceuticals, Approval
Lexiva (fosamprenavir calcium) Tablets, ViiV Healthcare Company, Labeling Revision
Lexiva (fosamprenavir calcium) Oral Suspension, ViiV Healthcare Company, Labeling Revision
Ranitidine Hydrochloride Tablets, Perrigo R&D Company, Approval
Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Venlafaxine Hydrochloride Extended-Release Capsules, Dr. Reddy's Laboratories, Ltd., Approval
Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision
Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision
Drug Shortages: Current Drug Shortages: Calcitriol 1 mcg/mL Injection
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
FDA Issues Warning Letters to Teva Pharmaceutical Industries and Moehs Cantabra for CGMP violations
Postmarketing Drug Safety Evaluations (updated)
New and Generic Drug Approvals
May 12, 2011
Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, Sandoz, Inc., Tentative Approval
Bromfenac Sodium Ophthalmic Solution, Coastal Pharmaceuticals, Approval
Dexamethasone Elixir, Vintage Pharmaceuticals, Approval
Lexiva (fosamprenavir calcium) Tablets, ViiV Healthcare Company, Labeling Revision
Lexiva (fosamprenavir calcium) Oral Suspension, ViiV Healthcare Company, Labeling Revision
Ranitidine Hydrochloride Tablets, Perrigo R&D Company, Approval
Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
Venlafaxine Hydrochloride Extended-Release Capsules, Dr. Reddy's Laboratories, Ltd., Approval
Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision
Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision
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