First-time generic approvals in May 2009

[chantell.reagan]

Azelastine nasal spray (generic* for Astelin) by Apotex

*Note: Final settlement with Apotex allows for generic launch on 3/1/2010 and Cobalt launch on 8/28/2010(sources: Meda press release 4/08; Meda press release 8/08)

Divalproex sodium 250mg, 500mg extended release tablets (AB rated generic* for Depakote ER) by various manufacturers

Levofloxacin 250mg, 500mg, 750mg tablets (AB rated generic* for Levaquin) by Lupin
(see related post: Generic Levaquin availability - noting generic may not be available until 6/2011)

Mycophenolate 250mg capsules, 500mg tablets (AB rated generic* for Cellcept) by various manufacturers

Ursodiol 250mg, 500mg tablets (AB rated generic* for Urso 250 and Urso Forte) by Teva

* Rating information not available
** 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