Drug Pipeline Progress - December 29-31 - Drug Discovery and Development

EMBEDA (morphine sulfate and naltrexone hydrochloride)
Company: King Pharmaceuticals, Inc.
FDA is continuing its review of the New Drug Application (NDA) for EMBEDA (morphine sulfate and naltrexone hydrochloride) extended release capsules, December 31, 2008
Company Comments: King Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) is continuing its review of the New Drug Application (NDA) for EMBEDA (morphine sulfate and naltrexone hydrochloride) extended release capsules. It is likely that this review will extend into early 2009.

Nicotine Polacrilex Gum USP
Company: Watson Pharmaceuticals
Received FDA Approval for Mint Coated Nicotine Gum, December 31, 2008
Company Comments: Watson Pharmaceuticals has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavor, in the 2 mg and 4 mg strengths.

Stavudine Capsules
Company: Mylan Inc.
Received Final FDA Approval for the Generic Version of the Antiretroviral Stavudine Capsules, December 29, 2008
Company Comments: Mylan Inc. received final approval from the U.S. Food and Drug Administration (FDA) on December 29, for its Abbreviated New Drug Application (ANDA) for Stavudine Capsules USP, 15 mg, 20mg, 30 mg, and 40 mg.

Mircette
Company: Watson Pharmaceuticals
Received FDA Final Approval for Generic Mircette, December 29, 2008
Company Comments: Watson Pharmaceuticals has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg.

balsalazide
Company: Salix Pharmaceuticals, Ltd.
Received FDA Complete Response Letter for balsalazide tablet, December 29, 2008
Company Comments: Based on its review, the FDA has determined that the application cannot be approved in its present form and that clinical data from an additional adequate and well-controlled clinical trial will be required in order to conduct further review on the NDA.

Ibuprofen PM
Company: Perrigo Company
Announced FDA Final Approval for Ibuprofen PM, December 29, 2008
Company Comments: Perrigo Company announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Ibuprofen and Diphenhydramine Citrate Tablets, 200/38 mg.