Drugs.com - New Drug Applications

Roche and FDA Agree on Pathway Towards U.S. Approval of Actemra (tocilizumab)

Thu, 04 Dec 2008 14:00:41 GMT

NUTLEY, N.J., December 04, 2008 /PRNewswire/ -- Roche today announced that the U.S. Food and Drug Administration (FDA) has provided further guidance on the requirements for the Biologics License Application (BLA) for Actemra (tocilizumab), the first...

Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for Community Acquired Pneumonia

Wed, 03 Dec 2008 19:15:11 GMT

CHICAGO, December 03, 2008 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's New Drug Application (NDA) for cethromycin, a novel...

Genta Receives Complete Response Letter from FDA to Amended Application of Genasense in Patients with Chronic Lymphocytic Leukemia

Wed, 03 Dec 2008 13:05:44 GMT

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Dec 2, 2008 - Genta Incorporated (OTCBB: GNTA.OB) today announced that the Company has received a complete response letter from the Office of Oncology Drug Products (OODP) at the Food and Drug Administration...

MedImmune Receives FDA Complete Response Letter on Motavizumab

Mon, 01 Dec 2008 12:35:46 GMT

LONDON, Nov. 28, 2008-AstraZeneca today announced that MedImmune, its wholly owned biologics business, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information on motavizumab....

FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections

Wed, 26 Nov 2008 14:15:55 GMT

RARITAN, N.J., November 26, 2008 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New...

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

Tue, 25 Nov 2008 13:15:05 GMT

DEERFIELD, Ill., and OSAKA, Japan, November 24, 2008 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory...

FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months

Mon, 24 Nov 2008 13:55:09 GMT

SAN DIEGO--(BUSINESS WIRE)--Nov 24, 2008 - Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of...

Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA

Mon, 24 Nov 2008 12:35:48 GMT

LAVAL, QC, November 24, 2008 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that its New Drug Application (NDA) for the Company's novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the...

FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema

Fri, 21 Nov 2008 17:20:38 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 21, 2008 - Dyax Corp. (NASDAQ: DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for DX-88 (ecallantide) for the...

Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome

Fri, 21 Nov 2008 15:25:38 GMT

REINACH, Switzerland, November 20, 2008 /PRNewswire-FirstCall/ -- Arpida announced today that the Anti-infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 17 to 2 against the approval of intravenous iclaprim,...

Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA

Thu, 20 Nov 2008 20:40:35 GMT

LONDON and BRENTWOOD, TN, Nov. 20, 2008 - Protherics PLC ("Protherics" or the "Company"), the international biopharmaceutical company focused on critical care and cancer, today announces that it has commenced the submission of a rolling Biologics...

Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer

Thu, 20 Nov 2008 16:30:46 GMT

BRIDGEWATER, N.J., November 20, 2008 /PRNewswire/ -- Ortho Biotech Products, L.P. today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with...

Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections

Thu, 20 Nov 2008 16:05:32 GMT

SOUTH SAN FRANCISCO, CA - NOVEMBER 19, 2008 - Theravance, Inc. announced today that telavancin received a favorable recommendation from the Anti-Infective Drugs Advisory Committee (AIDAC) of the U.S. Food and Drug Administration (FDA) for the...

FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date

Thu, 20 Nov 2008 15:46:00 GMT

ROCKVILLE, Md., November 20, 2008 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. , a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, reported...

FDA Extends Metozolv ODT Review Date

Tue, 18 Nov 2008 19:55:49 GMT

RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. today announced that the U.S. Food and Drug Administration (FDA) has informed Wilmington Pharmaceuticals that the Prescription Drug User Fee Act action date for the New Drug Application...

Altus Pharmaceuticals Reaffirms Plan to Submit New Drug Applicationfor Trizytek Approval

Mon, 17 Nov 2008 17:30:12 GMT

WALTHAM, Mass.-- Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced today that it is reaffirming its plan to submit a new drug application (NDA) for Trizytek (liprotamase) in the first-half of 2009. Trizytek is a non-porcine derived enzyme...

ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve

Fri, 14 Nov 2008 13:55:20 GMT

IRVINE, Calif., November 13, 2008 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. , today announced the Company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Bepreve (bepotastine ophthalmic solution)....

AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA

Thu, 13 Nov 2008 15:25:12 GMT

LEXINGTON, Mass.--(BUSINESS WIRE)--Nov 13, 2008 - AMAG Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's resubmission to the October 2008 Complete Response letter for its New Drug...

FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin

Mon, 10 Nov 2008 16:35:40 GMT

WARRINGTON, Pa., Nov. 7, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Discovery Labs' Complete Response for Surfaxin (lucinactant) for the prevention...

GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome

Mon, 10 Nov 2008 14:25:37 GMT

RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif.--(BUSINESS WIRE)--Nov 10, 2008 - GlaxoSmithKline and XenoPort, Inc. announced today that the New Drug Application (NDA) for Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment...

BioDelivery Sciences to Meet with FDA to Finalize Proposed REMS for Onsolis

Fri, 07 Nov 2008 14:25:33 GMT

RALEIGH, N.C.--(BUSINESS WIRE)--Nov 7, 2008 - BioDelivery Sciences International, Inc. announced that a meeting with the Food and Drug Administration (FDA) is scheduled for November 17, 2008, to discuss its proposed Risk Evaluation and Mitigation...

Sanofi-aventis to Discontinue all Clinical Trials with rimonabant

Thu, 06 Nov 2008 16:45:25 GMT

Paris, November 5, 2008 - Sanofi-aventis announced today that it has decided to discontinue the ongoing rimonabant clinical development program in all indications. Today’s company decision has been taken in light of recent demands by certain...

Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal

Thu, 06 Nov 2008 14:40:08 GMT

BARCELONA, Spain, November 05, 2008 /PRNewswire/ -- Salvat announced today the submission of the response to the FDA Approvable Letter for Cetraxal (Ciprofloxacin 0.2% Otic Solution in Single Dose Containers). In an Approvable Letter received on...

Debiopharm Submits Response to the FDA for Sanvar (Debio 8609) for Esophageal Variceal Bleeding

Thu, 06 Nov 2008 14:30:18 GMT

Lausanne, Switzerland, November 4, 2008 - Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today that Debiovision Inc., its Canadian...

Savient Submits Biologics License Application (BLA) for Pegloticase

Fri, 31 Oct 2008 14:40:26 GMT

EAST BRUNSWICK, N.J., October 31, 2008 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. today announced the submission of its BLA to the U.S. Food and Drug Administration (FDA) seeking approval to market pegloticase in the United States along...

Erbitux Supplemental Biologics License Application for First-Line Recurrent or Metastatic Head and Neck Cancer Accepted for Priority Review by U.S. Food and Drug Administration

Fri, 31 Oct 2008 13:15:05 GMT

NEW YORK--(BUSINESS WIRE)--Oct 30, 2008 - ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the companies'...

Northfield Laboratories Inc. Announces Submission of BLA for PolyHeme

Wed, 29 Oct 2008 16:05:33 GMT

EVANSTON, Ill.--(BUSINESS WIRE)--Oct 29, 2008 - Northfield Laboratories Inc. announced today it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for PolyHeme, the Company's human hemoglobin-based red cell...

Kowa Announces NDA Submission and MAA Filing for HMG CoA Reductase Inhibitor Pitavastatin

Tue, 28 Oct 2008 13:05:45 GMT

NAGOYA, Japan, October 27, 2008 - Kowa Company, Ltd. (Kowa), headquartered in Nagoya, Japan, today announced that Kowa has submitted a New Drug Application dated October 1 to the US Food and Drug Administration (FDA) for Pitavastatin Calcium...

Digestive Care, Inc. Announces the Complete Submission of the NDA for Pancrecarb (pancrelipase)

Mon, 27 Oct 2008 19:40:17 GMT

BETHLEHEM, Pa., October 27, 2008 /PRNewswire/ -- Digestive Care, Inc. (DCI) announced today that it has completed the submission of the New Drug Application ("NDA") for Pancrecarb (pancrelipase), used in the treatment of Exocrine Pancreatic...

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate

Fri, 24 Oct 2008 13:35:43 GMT

RARITAN, N.J., October 24, 2008 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for carisbamate, a...

NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)

Wed, 22 Oct 2008 14:20:48 GMT

SAN MATEO, Calif., October 22, 2008 /PRNewswire-FirstCall/ -- NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that it has submitted a new drug application (NDA)...

KV Provides Update on Gestiva PDUFA Date

Tue, 21 Oct 2008 18:50:59 GMT

ST. LOUIS, October 20, 2008 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company announced today that it was advised by Hologic, Inc., the holder of the New Drug Application (NDA) for Gestiva, that the U.S. Food and Drug Administration (FDA) has...

Intercell making strides towards imminent approval of its Japanese Encephalitis vaccine in the United States –Approvals in United States, Europe and Australia remain on track for 2008

Tue, 21 Oct 2008 14:05:04 GMT

VIENNA, Austria, October 20, 2008 – Following the positive feedback from the FDA, Intercell announced today an update on the regulatory approval processes for its Japanese Encephalitis vaccine in the United States, Europe and Australia. In the...

FDA Defers Final Action on Milnacipran New Drug Application

Mon, 20 Oct 2008 15:30:24 GMT

NEW YORK and SAN DIEGO, October 20, 2008 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Cypress Bioscience, Inc. (the "Companies") today announced that the U.S. Food and Drug Administration (FDA) has advised the Companies that it was not...

NexMed Discusses End of Review Meeting for Vitaros

Mon, 20 Oct 2008 13:50:41 GMT

EAST WINDSOR, N.J.--(BUSINESS WIRE)--Oct 20, 2008 - NexMed, Inc., a developer of innovative treatments based on the NexACT technology, announced today that it met with the Food and Drug Administration (FDA) on October 15, 2008 concerning Vitaros,...

Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS

Mon, 20 Oct 2008 13:00:18 GMT

WARRINGTON, Pa., Oct. 17, 2008 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today submitted its Complete Response to the May 2008 Approvable Letter issued by the U.S. Food and Drug Administration (FDA) for Surfaxin (lucinactant)...

AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol

Mon, 20 Oct 2008 12:15:32 GMT

LEXINGTON, Mass.--(BUSINESS WIRE)--Oct 20, 2008 - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for ferumoxytol for the treatment of iron...

FDA Adds Three Months to Review of Takeda's New Drug Application for TAK-390MR

Mon, 20 Oct 2008 11:50:05 GMT

OSAKA, Japan, October 20, 2008 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary received notification from the...

Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application

Fri, 17 Oct 2008 12:20:58 GMT

TOKYO and INDIANAPOLIS, October 16, 2008 /PRNewswire-FirstCall/ -- In response to recent media speculation regarding the status of the prasugrel new drug application (NDA), Daiichi Sankyo Company, Limited and Eli Lilly and Company reiterated today...

Targanta Announces Review of Oritavancin at FDA Anti-Infective Drugs Advisory Committee Meeting

Wed, 15 Oct 2008 19:20:08 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct 14, 2008 - Targanta Therapeutics Corporation announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee will review the Company's New Drug Application (NDA) for...