New and Generic Drug Approvals

New and Generic Drug Approvals

August 24, 2011

Butalbital and Acetaminophen Tablets, Nexgen Pharma, Inc., Approval
Copegus (ribavirin) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
Gatifloxacin Ophthalmic Solution, Apotex Corp., Approval
Humatrope (somatropin [rDNA origin]) Injection, Eli Lilly and Co.,
Labeling Revision
Kerledex (betaxolol hydrochloride and chlorthalidone) Tablets,
sanofi-aventis, Labeling Revision
Pegasys (peginterferon alfa-2a) Vial, Hoffmann-La Roche, Inc., Labeling Revision
Verdeso (desonide) Foam, Stiefel Laboratories, Inc., Labeling Revision
Xanax (alprazolam) Tablets, Pfizer Inc., Labeling Revision
Xanax XR (alprazolam) Extended-Release Tablets, Pfizer Inc., Labeling Revision
Zyban (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision

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