Drugs.com - New Drug Applications

ATryn (antithrombin alfa) BLA Filing Accepted by FDA

Mon, 06 Oct 2008 16:50:18 GMT

DEERFIELD, Ill., Oct. 6, 2008--BUSINESS WIRE-OVATION Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ATryn (antithrombin alfa). OVATION...

Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings

Wed, 01 Oct 2008 14:35:07 GMT

PT. RICHMOND, Calif., Oct. 1 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for...

New Drug Application (NDA) for Lipsovir submitted to US FDA

Wed, 01 Oct 2008 13:35:20 GMT

HUDDINGE, Sweden, Oct. 1, 2008-Medivir has today submitted an NDA to the US Food & Drug Administration (FDA) for Lipsovir, a topical product for prevention and treatment of cold sores. Lipsovir is a patented combination of hydrocortisone (an...

Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia

Wed, 01 Oct 2008 12:30:23 GMT

CHICAGO, Oct. 1 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. today announced the submission of a new drug application (NDA) for cethromycin in mild-to-moderate community acquired pneumonia (CAP). Advanced Life Sciences also...

FDA Continues to Review Prasugrel New Drug Application

Mon, 29 Sep 2008 13:40:12 GMT

TOKYO and INDIANAPOLIS, Sept. 26 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited, and Eli Lilly and Company confirmed today that the U.S. Food and Drug Administration (FDA) did not complete its review for the prasugrel new drug application...

Indevus and FDA Agree on Path Forward for Nebido

Fri, 26 Sep 2008 14:25:23 GMT

LEXINGTON, Mass., September 26, 2008 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) with regard to the additional data and risk management...

Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin

Wed, 24 Sep 2008 15:50:04 GMT

WARRINGTON, Pa., Sept. 24, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. announces that it has achieved technical success in addressing the key remaining requirements identified by the U.S. Food and Drug Administration (FDA) to gain...

Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes

Wed, 24 Sep 2008 13:20:25 GMT

OSAKA, Japan, September 23, 2008 /PRNewswire/Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), submitted a New Drug Application (NDA) to the...

Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema

Wed, 24 Sep 2008 13:10:44 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep 24, 2008 - Dyax Corp. announced today the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax's lead product candidate DX-88 (ecallantide)...

Genzyme Announces FDA Priority Review for Mozobil New Drug Application

Tue, 23 Sep 2008 19:20:10 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep 23, 2008 - Genzyme Corporation today provided updates on three therapies with regulatory actions anticipated by year end. The company reported that it expects FDA to act on its biologic license application...

FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma

Tue, 23 Sep 2008 12:45:45 GMT

BROOMFIELD, Colo., September 23, 2008 /PRNewswire/ -- ARCA biopharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for the company's lead product candidate, bucindolol, an...

Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression

Mon, 22 Sep 2008 13:45:32 GMT

LAVAL, QC, September 22, 2008 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act to the U.S. Food and Drug Administration...

NovaDel Pharma Announces PDUFA Deadline Extension on Zolpimist

Fri, 19 Sep 2008 13:40:27 GMT

FLEMINGTON, N.J,--(BUSINESS WIRE)--Sept. 18, 2008 - NovaDel Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has requested an extension of up to 3 months on the Prescription Drug User Fee Act (PDUFA) deadline in order to...

FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application

Thu, 18 Sep 2008 18:05:05 GMT

NUTLEY, N.J., September 18, 2008 /PRNewswire/ -- Roche today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the Biologics License Application (BLA) for Actemra (tocilizumab), the first...

Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis

Wed, 17 Sep 2008 13:15:33 GMT

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep 16, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for...

GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome

Tue, 16 Sep 2008 13:25:27 GMT

RESEARCH TRIANGLE PARK, N.C. and SANTA CLARA, Calif., September 16, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA)...

FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter

Mon, 15 Sep 2008 20:45:05 GMT

BASEL, Switzerland, September 15, 2008 - Basilea Pharmaceutica Ltd. announces that the Food and Drug Administration (FDA) has accepted for review the Complete Response to the ceftobiprole New Drug Application (NDA) Approvable Letter. The Complete...

Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia

Mon, 15 Sep 2008 13:30:19 GMT

COPENHAGEN, Denmark, Sept. 15, 2008-H. Lundbeck A/S announced today that the U.S. Food and Drug Administration (FDA) has completed the initial check for completeness and accepted the New Drug Application on Serdolect for the treatment of...

Pro-Pharmaceuticals Submits Data to FDA for Davanat NDA to Treat Advanced Colorectal Cancer

Mon, 15 Sep 2008 12:45:16 GMT

NEWTON, Mass.--(BUSINESS WIRE)--Sep 15, 2008 - Pro-Pharmaceuticals, Inc., a bio-pharmaceutical company developing proprietary polysaccharide-based therapeutic compounds to treat cancer, has submitted supporting clinical and manufacturing data to the...

Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial

Tue, 09 Sep 2008 14:35:05 GMT

NEW YORK--(BUSINESS WIRE)--Sep 9, 2008 - Pfizer Inc today announced it will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. new drug...

Introgen Receives Notice Advexin U.S. BLA Not Sufficiently Complete to File

Tue, 02 Sep 2008 13:05:04 GMT

AUSTIN, Texas--(BUSINESS WIRE)--Sep 2, 2008 - Introgen Therapeutics, Inc., a developer of targeted molecular therapies for cancer, today announced that the United States Food and Drug Administration (FDA) notified the Company that its Biologics...

Alpharma Announces Acceptance of the Embeda Capsule NDA Filing

Tue, 02 Sep 2008 12:50:11 GMT

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Sep 2, 2008 - Alpharma Inc., a global specialty pharmaceutical company, today announced that the United States Food and Drug Administration ("FDA") has advised the Company that its New Drug Application ("NDA") for...

BioDelivery Sciences Anticipates First Half 2009 Approval of BEMA Fentanyl (Onsolis)

Thu, 28 Aug 2008 13:45:03 GMT

RALEIGH, N.C.--(BUSINESS WIRE)--Aug. 28, 2008 - BioDelivery Sciences International, Inc. (Nasdaq:BDSI) today announced receipt of a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug...

FDA Issues Complete Response Letter for Paliperidone Palmitate for the Treatment of Schizophrenia

Wed, 27 Aug 2008 12:10:22 GMT

TITUSVILLE, N.J., August 26, 2008 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional data before it will approve the company's...

Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For Kynapid

Mon, 11 Aug 2008 14:50:01 GMT

VANCOUVER and DEERFIELD, IL, August 11, 2008 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. and its co-development partner Astellas Pharma US, Inc. ("Astellas") today announced that they have received an action letter dated August 8, 2008 from the...

Multaq (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation

Fri, 08 Aug 2008 14:05:46 GMT

BRIDGEWATER, N.J., August 08, 2008 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that U.S. Food and Drug Administration (FDA) has assigned priority review status for its New Drug Application (NDA) for Multaq (dronedarone). The priority...

FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months

Fri, 08 Aug 2008 14:05:17 GMT

HORSHAM, Pa., August 08, 2008 /PRNewswire/ -- Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by...

Othera Files IND Application for OT-730 in Glaucoma

Fri, 08 Aug 2008 00:45:30 GMT

EXTON, Pa.--(BUSINESS WIRE)--Jul 30, 2008 - Othera Pharmaceuticals, Inc., announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OT-730, an oculoselective beta-blocker, as a...

GTC Biotherapeutics Completes BLA Submission For ATryn

Thu, 07 Aug 2008 21:05:03 GMT

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Aug 7, 2008 - GTC Biotherapeutics, Inc. has completed its submission of the final portion of the Biologics License Application, or BLA, for ATryn in the United States. The final portion of the BLA submission...

Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter

Wed, 06 Aug 2008 14:55:24 GMT

Discovery Labs Reports Progress in Responding to Surfaxin FDA Approvable Letter WARRINGTON, Pa., Aug. 6, 2008 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. announces that it has made significant progress in addressing key remaining requirements...

U.S. FDA Issues Action Letter for Sugammadex

Fri, 01 Aug 2008 12:35:03 GMT

KENILWORTH, N.J., Aug. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the reversal of...

Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S.

Wed, 30 Jul 2008 12:25:57 GMT

Rivaroxaban is first oral anticoagulant to achieve superior efficacy over the twice-daily injection of enoxaparin while maintaining low rates of major bleeding No evidence of safety issues attributable to rivaroxaban after long-term...

FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis

Tue, 29 Jul 2008 21:15:38 GMT

First interleukin-6 (IL-6) inhibitor to offer new therapeutic option for rheumatoid arthritis NUTLEY, N.J., July 29, 2008 /PRNewswire/ -- Roche today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by...

UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain

Tue, 29 Jul 2008 19:25:31 GMT

BRUSSELS, Belguim, July 29, 2008--UCB announced today that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults. The company will seek...

Meda: The FDA has accepted for filing the registration application for Sublinox

Tue, 29 Jul 2008 12:50:04 GMT

STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News: The submitted registration application for Sublinox has been accepted by the FDA as complete for substantive review after initial evaluation. Sublinox contains the well-known active substance...

Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone

Mon, 28 Jul 2008 16:35:19 GMT

ROCKVILLE, Md., July 28, 2008 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. announced today the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an...

Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures

Mon, 28 Jul 2008 16:25:08 GMT

FDA's Not Approvable Letter Outlines Pathway to Potential Approval WOODCLIFF LAKE, N.J., July 25, 2008 /PRNewswire/ -- Eisai Corporation of North America today announced that it has received a not approvable letter from the U.S. Food and Drug...

Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for Onglyza (saxagliptin) for the Treatment of Type 2 Diabetes

Wed, 23 Jul 2008 13:35:18 GMT

PRINCETON, N.J. & LONDON--(BUSINESS WIRE)--July 23, 2008--Bristol-Myers Squibb Company and AstraZeneca today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and validation of a...

NexMed Receives FDA Response for Topical ED Product

Wed, 23 Jul 2008 13:15:21 GMT

EAST WINDSOR, N.J.--(BUSINESS WIRE)--July 22, 2008 - NexMed, Inc. today announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for...

Xanodyne Receives Approvable Letter From the FDA for Zipsor Capsules

Tue, 22 Jul 2008 12:55:56 GMT

NEWPORT, Ky.--(BUSINESS WIRE)--Jul 22, 2008 - Xanodyne Pharmaceuticals, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zipsor, its candidate for the treatment of patients with mild...