What is new in FDA

June 23, 2011

Bad Ad Looks Good in Year One (podcast)
CDER Drug and Biologic Approvals for Calendar Year 2010
CDER New Molecular Entity (NME) Drug and New Biologic Approvals in 2009 (updated)
Drugs@FDA Download File (updated)
Drug Firm Annual Registration Status (updated)
Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 7(R2) Dissolution Test General Chapter (PDF - 102KB)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
New and Generic Drug Approvals

June 23, 2011

Busulfex (busulfan) Injection, Otsuka Pharmaceutical Development & Commercialization, Inc., Labeling Revision
Celontin (methsuximide) Capsules, Pfizer, Inc., Labeling Revision
Clobetasol Propionate Topical Spray, Paddock Laboratories, Inc., Approval
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules, Watson Laboratories, Labeling Revision
Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
Kenalog-10 (triamcinolone acetonide) Injection, Bristol-Meyers Squibb, Labeling Revision
Kenalog-40 (triamcinolone acetonide) Injection, Bristol-Meyers Squibb, Labeling Revision
Livalo (pitavastatin calcium) Tablets, Kowa Company Limited, Labeling Revision
Niravam (alprazolam) Orally Disintegrating Tablets, UCB, Inc., Labeling Revision
Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, AstraZeneca LP, Manufacturing Supplement
Renvela (sevelamer carbonate) Oral Suspension, Genzyme Corporation, Labeling Revision
Renvela (sevelamer carbonate) Tablets, Genzyme Corporation, Labeling Revision
Sucraid (sacrosidase) Oral Solution, QOL Medical LLC, Labeling Revision
Talacen (pentazocine hydrochloride, and acetaminophen) Tablets, Sanofi Aventis, Labeling Revision
Thallous Chloride Tl 201 Injection, Mallinckrodt Inc., Labeling Revision
Torisel (temsirolimus) I.V. Solution, Pfizer Inc., Labeling Revision
Trimethoprim Tablets, Novel Laboratories, Inc., Approval
Ultracet (tramadol hydrochloride and acetaminophen) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
Venofer (iron sucrose) Injection, Luitpold Pharmaceuticals, Inc., Labeling Revision
Zarontin (ethosuximide) Capsules, Pfizer, Inc., Labeling Revision
Zenpep (pancrelipase) Delayed-Release Capsules, Eurand Pharmaceuticals, Inc., Manufacturing Supplement