New and Generic Drug Approvals
July 13, 2011
Creon (pancrelipase) Delayed-Release Capsules, Abbott Products, Inc.,
Efficacy Supplement
Dexamethasone Elixir, Lyne Laboratories, Inc., Approval
Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Paxil (paroxetine hydrochloride) Oral Suspension, GlaxoSmithKline,
Labeling Revision
Paxil CR Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
Seroquel XR (quetiapine fumarate) Extended-Release Tablets,
AstraZeneca Pharmaceuticals, Labeling Revision
Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets,
Gilead Sciences, Inc., Labeling Revision
Ursodiol Tablets, Glenmark Generics, Inc., Approval
Venlafaxine Hydrochloride Extended-Release Capsules, Orchid Healthcare, Approval
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