New Drug Application News and Research

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FDA approves Perrigo's ANDA for OTC Miconazole Nitrate Vaginal Cream and Suppository

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat® -1 Combination Pack. Perrigo expects to begin shipping immediately.

4 Jun 2010

Taro's granisetron tablets receive FDA approval

Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Granisetron Hydrochloride Tablets USP, 1 mg (base) ("granisetron tablets").

3 Jun 2010

Biovail: BLS, Kyowa Hakko Kirin sign license agreement

Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL, has entered into a license agreement with Kyowa Hakko Kirin Co., Ltd. BLS has acquired the U.S. and Canadian rights to commercialize products containing istradefylline - a new chemical entity targeted for the treatment of Parkinson's disease.

3 Jun 2010

ACT Biotech's Telatinib receives orphan drug designation from FDA for treatment of gastric cancer

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, announced today that the company's highly selective oral kinase inhibitor, Telatinib, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of gastric cancer.

3 Jun 2010

FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg

Eisai Inc. (Headquarters: Woodcliff Lake, NJ; Chairman and CEO: Hajime Shimizu), a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito) today announced that the U.S. Food and Drug Administration has accepted Eisai's New Drug Application for rabeprazole sodium extended-release 50 mg for the healing and maintenance of healing of erosive gastroesophageal reflux disease, and for the treatment of symptomatic GERD.

3 Jun 2010

FDA grants priority review status to Eisai's eribulin NDA

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted priority review status to the company's New Drug Application (NDA) for the investigational agent eribulin mesylate ("eribulin," also known as E7389). Eisai is seeking FDA approval for eribulin in the treatment of patients with locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens, including an anthracycline and a taxane.

2 Jun 2010

Onyx Pharmaceuticals commences Phase 1 study of ONX 0912 oral proteasome inhibitor for cancer

Onyx Pharmaceuticals, Inc. today announced the initiation of a Phase 1 study of ONX 0912, an oral proteasome inhibitor, in patients with advanced refractory or recurrent solid tumors.

2 Jun 2010

FDA accepts Orexigen's Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity.

2 Jun 2010

Teva Pharmaceutical launches Gianvi Tablets

Teva Pharmaceutical Industries Ltd. announced today that it has commercially launched Gianvi (Drospirenone and Ethinyl Estradiol) Tablets, the Company's generic version of Bayer's Yaz® Tablets.

2 Jun 2010

EpiCept provides update on post-approval commitments requested by EMA for Ceplene

EpiCept Corporation today provided an update on the post-approval commitments requested by the European Medicines Agency as part of its marketing authorization for Ceplene (histamine dihydrochloride). Ceplene is approved in the EU for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia in first complete remission.

1 Jun 2010

Shire receives Paragraph IV Notice Letter from Zydus over filing of ANDA for generic LIALDA

Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter today from Zydus Pharmaceuticals USA, Inc. advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Shire's 1.2g mesalamine delayed release tablets, LIALDA(R).

29 May 2010

FDA approves Cysview for detection of non-muscle-invasive papillary cancer of bladder

GE Healthcare, a unit of General Electric Company, today announced that the US Food and Drug Administration has approved Cysview (hexaminolevulinate HCl) for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer.

29 May 2010

Alimera Sciences provides new data from Iluvien Phase 3 FAME clinical trials for DME

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that a new analysis of data from its Phase 3 (FAME) clinical trials for Iluvien, the company's investigational intravitreal insert being studied for diabetic macular edema (DME), indicates that patient vision continues to improve significantly over 30 months.

28 May 2010

US District Court dismisses all claims and counterclaims in thalidomide patent cases

Celgene Corporation announced that as a result of Barr Laboratories, Inc., withdrawing its Abbreviated New Drug Application (ANDA) for thalidomide with the US Food and Drug Administration, the US District Court for the District of New Jersey has granted the requested dismissal of all claims and counterclaims in the thalidomide patent cases.

27 May 2010

FDA accepts Horizon Pharma's DUEXA NDA for review

Horizon Pharma, Inc., a late-stage biopharmaceutical company focused on the development and commercialization of innovative medicines for pain-related diseases and inflammation, today announced that its New Drug Application (NDA) for DUEXA®, a proprietary tablet formulation containing a fixed-dose combination of ibuprofen and high-dose famotidine, was accepted by the U.S. Food and Drug Administration (FDA) for review.

27 May 2010

FDA approves Mylan's ANDA for Valacyclovir Hydrochloride Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Valacyclovir Hydrochloride Tablets, 500 mg (base) and 1000 mg (base), the generic version of GlaxoSmithKline's Valtrex, a treatment for the herpes virus infection.

26 May 2010

Gentium first-quarter net loss decreases to EUR 0.03 million

Gentium S.p.A. today reported financial results for the quarter ended March 31, 2010. The Company reports its financial condition and operating results using U.S. Generally Accepted Accounting Principles (GAAP).

26 May 2010

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.

26 May 2010

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder in adolescents aged 13 to 17 years.

26 May 2010

Vertex reports 75% patients with HCV achieve viral cure with 12-week telaprevir-based combination regimen

Vertex Pharmaceuticals Incorporated today announced that 75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial.

26 May 2010

New Drug Application News and Research

FDA approves Perrigo's ANDA for OTC Miconazole Nitrate Vaginal Cream and Suppository

Taro's granisetron tablets receive FDA approval

Biovail: BLS, Kyowa Hakko Kirin sign license agreement

ACT Biotech's Telatinib receives orphan drug designation from FDA for treatment of gastric cancer

FDA accepts Eisai's NDA for rabeprazole sodium extended-release 50 mg

FDA grants priority review status to Eisai's eribulin NDA

Onyx Pharmaceuticals commences Phase 1 study of ONX 0912 oral proteasome inhibitor for cancer

FDA accepts Orexigen's Contrave NDA for treatment of obesity

Teva Pharmaceutical launches Gianvi Tablets

EpiCept provides update on post-approval commitments requested by EMA for Ceplene

Shire receives Paragraph IV Notice Letter from Zydus over filing of ANDA for generic LIALDA

FDA approves Cysview for detection of non-muscle-invasive papillary cancer of bladder

Alimera Sciences provides new data from Iluvien Phase 3 FAME clinical trials for DME

US District Court dismisses all claims and counterclaims in thalidomide patent cases

FDA accepts Horizon Pharma's DUEXA NDA for review

FDA approves Mylan's ANDA for Valacyclovir Hydrochloride Tablets

Gentium first-quarter net loss decreases to EUR 0.03 million

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Vertex reports 75% patients with HCV achieve viral cure with 12-week telaprevir-based combination regimen

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