New Drug Application News and Research

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VIVUS submits avanafil NDA to FDA for treatment of erectile dysfunction

VIVUS, Inc. today announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction.

30 Jun 2011

Almirall, Forest Labs submit aclidinium bromide NDA to FDA for treatment of COPD

Forest Laboratories, Inc. and Almirall, S.A. announced they have recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aclidinium bromide, a long-acting inhaled antimuscarinic agent developed for the treatment of COPD.

30 Jun 2011

A.P. Pharma enters into definitive agreements for $24M private placement of common stock and warrants

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that it has entered into definitive agreements with certain new and existing accredited investors providing for a private placement of common stock and warrants in which the Company will receive $24 million in gross proceeds.

29 Jun 2011

Researchers, policy experts to examine issue of declining enrollment in clinical trials

Leading researchers and policy experts from across the country will come together June 27 and June 28 at Mount Sinai School of Medicine in New York to examine the issue of declining enrollment in clinical trials.

28 Jun 2011

Marshall Edwards' Triphendiol pre-clinical study data now available in Anti-Cancer Drugs website

Marshall Edwards, Inc., an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today the publication of results from pre-clinical studies of Triphendiol, a prodrug of the Company's lead drug candidate NV-143, that demonstrate its anti-proliferative activity in pancreatic cancer as both a monotherapy and as a chemosensitizer.

28 Jun 2011

FDA accepts for filing Columbia's PROCHIEVE progesterone gel NDA

Columbia Laboratories, Inc. and Watson Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application (NDA) for PROCHIEVE (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy.

27 Jun 2011

FDA issues Complete Response Letter for Pfizer's REMOXY NDA

DURECT Corporation today reported that Pfizer Inc. has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY, a controlled-release form of oxycodone designed to discourage common methods of tampering.

27 Jun 2011

FDA approves Laureate's Electronic Submission Gateway application

Laureate Biopharmaceutical Services, Inc. announced today that the U.S. Food and Drug Administration ("FDA") approved its application for an Electronic Submissions Gateway (ESG) to the Agency.

24 Jun 2011

FDA approves Lannett's NDA for Morphine Sulfate Oral Solution

Lannett Company, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the company's 505(b)(2) New Drug Application (NDA) for Morphine Sulfate Oral Solution on June 23, 2011.

24 Jun 2011

Pfizer and Pain Therapeutics receive FDA Complete Response Letter for resubmission of REMOXY NDA

Pfizer and Pain Therapeutics, Inc. announced that a Complete Response Letter was received from the U.S. Food and Drug Administration (FDA) on the resubmission to the new drug application (NDA) for REMOXY® (oxycodone) Extended-Release Capsules CII. Pfizer is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA around them.

24 Jun 2011

Endo's complete response for new formulation of OPANA ER NDA accepted by the FDA

Endo Pharmaceuticals announced today that it received notification from the U.S. Food and Drug Administration (FDA) that Endo's complete response to the FDA's Jan. 7, 2011 Action Letter relating to Endo's new drug application (NDA) for a new formulation of OPANA ER has been accepted.

24 Jun 2011

Mylan introduces generic Entocort EC capsules for treatment of Crohn's disease

Mylan Inc. today announced that the U.S. District Court for the District of Delaware has found after trial that Mylan subsidiary Mylan Pharmaceuticals Inc. does not infringe the asserted claims of U.S. Patent No. 5,643,602 with its Abbreviated New Drug Application for Budesonide Capsules, 3 mg, the generic version of AstraZeneca's Entocort EC capsules, a treatment for Crohn's disease.

24 Jun 2011

USPTO issues Notice of Allowance for Neurocrine's NBI-98854 to treat tardive dyskinesia

Neurocrine Biosciences, Inc. announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the Company's proprietary Vesicular Monoamine Transporter 2 inhibitor, NBI-98854.

24 Jun 2011

MAP to present LEVADEX data on migraine at 15th Congress of IHC

MAP Pharmaceuticals, Inc. today announced that LEVADEX orally inhaled migraine drug will be featured in four poster presentations, including one late-breaker presentation, at the 15th Congress of the International Headache Society (IHC) in Berlin, Germany on June 23-26, 2011.

23 Jun 2011

Watson Pharmaceuticals expands Salt Lake City R&D and manufacturing facility

Watson Pharmaceuticals, Inc., today formally announced an approximately $44 million expansion of its Salt Lake City, Utah, Watson Laboratories, Inc. site.

23 Jun 2011

LPI receives final FDA approval for generic version of Levaquin tablets

Lupin Pharmaceuticals, Inc. (LPI) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of Ortho McNeil's Levaquin tablets.

23 Jun 2011

22nd Century submits IND to FDA for VLN cigarettes

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction, announced today that 22nd Century Limited, LLC submitted an Investigational New Drug Application (IND) to the U.S. Food & Drug Administration (FDA) for X-22, a prescription smoking cessation aid in development.

22 Jun 2011

EC grants marketing authorization to BYDUREON for treatment of type 2 diabetes

Eli Lilly and Company, together with Amylin Pharmaceuticals, Inc. and Alkermes, Inc., announced today that the European Commission has granted marketing authorization to BYDUREON.

21 Jun 2011

Lorcaserin Phase 3 trial data on type 2 diabetes to be presented at ADA 2011

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that lorcaserin data from the Phase 3 BLOOM-DM trial will be presented in poster sessions at the American Diabetes Association's (ADA) 71st Scientific Sessions in San Diego, California.

21 Jun 2011

Genentech to present positive data from vismodegib Phase II trial on advanced BCC at EADO 2011

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that positive data are being presented by its collaborator Genentech, a member of the Roche Group, from a pivotal Phase II clinical trial conducted by Roche and Genentech of vismodegib in patients with advanced basal cell carcinoma, an often life-threatening form of skin cancer that can have disfiguring and debilitating effects.

20 Jun 2011

New Drug Application News and Research

VIVUS submits avanafil NDA to FDA for treatment of erectile dysfunction

Almirall, Forest Labs submit aclidinium bromide NDA to FDA for treatment of COPD

A.P. Pharma enters into definitive agreements for $24M private placement of common stock and warrants

Researchers, policy experts to examine issue of declining enrollment in clinical trials

Marshall Edwards' Triphendiol pre-clinical study data now available in Anti-Cancer Drugs website

FDA accepts for filing Columbia's PROCHIEVE progesterone gel NDA

FDA issues Complete Response Letter for Pfizer's REMOXY NDA

FDA approves Laureate's Electronic Submission Gateway application

FDA approves Lannett's NDA for Morphine Sulfate Oral Solution

Pfizer and Pain Therapeutics receive FDA Complete Response Letter for resubmission of REMOXY NDA

Endo's complete response for new formulation of OPANA ER NDA accepted by the FDA

Mylan introduces generic Entocort EC capsules for treatment of Crohn's disease

USPTO issues Notice of Allowance for Neurocrine's NBI-98854 to treat tardive dyskinesia

MAP to present LEVADEX data on migraine at 15th Congress of IHC

Watson Pharmaceuticals expands Salt Lake City R&D and manufacturing facility

LPI receives final FDA approval for generic version of Levaquin tablets

22nd Century submits IND to FDA for VLN cigarettes

EC grants marketing authorization to BYDUREON for treatment of type 2 diabetes

Lorcaserin Phase 3 trial data on type 2 diabetes to be presented at ADA 2011

Genentech to present positive data from vismodegib Phase II trial on advanced BCC at EADO 2011

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