First-time generic approvals in August 2009

[chantell.reagan]

Benzoyl peroxide 5%/clindamycin 1% gel (AB rated generic* for Benzaclin) by Dow Pharm Sciences

Clonidine TDS (AB rated generic* for Catapres TTS patch) by Par Pharmaceuticals/Aveva

•Link to Par press release 8/09

Levonorgestrel 0.75mg tablet (AB rated generic* for Plan B OTC) by Watson

Tacrolimus capsules (AB rated generic* for Prograf) by Sandoz

* The key to the FDA’s Therapeutic Equivalence Evaluation Codes is available at: Orange Book Annual Preface

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: First Time Generics and Drugs@FDA

U.S. Food and Drug Administration. Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: Orange Book Annual Preface