What's New on the FDA Drugs Site

June 24, 2011

Drug Shortages: Current Drug Shortages: Calcium Gluconate (updated)
Drug Shortages: Current Drug Shortages: Digoxin Injection (updated)
Drug Shortages: Current Drug Shortages: Leuprolide Injection
Drug Shortages: Current Drug Shortages: Mitomycin Powder for Injection
Drug Shortages: Current Drug Shortages: Phenylephrine HCl Injection (updated)
Drug Shortages: Resolved Drug Shortages: Erythromycin lactobionate injection
Drug Shortages: Resolved Drug Shortages: Tamiflu for Oral Suspension
Drug Shortages: Resolved Drug Shortages: Thyroid (desiccated) tablets
Drug Shortages: Resolved Drug Shortages: Tromethamine
FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. (updated)
New and Generic Drug Approvals

June 24, 2011

Caprelsa (vandetanib) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
Istodax (romidepsin) I.V. Powder, Celgene Corporation, New or Modified Indication
Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca LP, Labeling Revision
Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca LP, Labeling Revision
Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca LP, Labeling Revision
Nexium (esomeprazole sodium) Intravenous Injection, AstraZeneca LP, Labeling Revision
Nulojix (belatacept) Injection, Bristol-Myers Squibb Company, Approval
Renagel (sevelamer hydrochloride) Tablets, Genzyme Corporation, Labeling Revision
Sumatriptan Succinate Subcutaneous Injection, Sun Pharmaceutical Industries, Inc., Approval
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules, Eli Lilly and Company, Labeling Revision
Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision
Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Labeling Revision
Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Company, Labeling Revision