The Daily Reviewer | Drugs.com - New Drug Applications

NicOx announces FDA Advisory Committee to discuss naproxcinod on May 12

Mar 8, 2010 9:02am

Sophia Antipolis, France, March 8, 2010. -NicOx S.A. today announces that on Wednesday, May 12, 2010, the US Food and Drug Administration (FDA) plans to hold a meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk... ...

InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone

Mar 5, 2010 6:10am

BRISBANE, Calif., March 5 /PRNewswire-FirstCall/ -- InterMune, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to... ...

FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone

Mar 2, 2010 1:17pm

SEATTLE, March 1 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee ("ODAC") will review CTI's New Drug Application ("NDA") for pixantrone for... ...

VIVUS Announces FDA Acceptance of Qnexa New Drug Application for Treatment of Obesity

Mar 2, 2010 11:00am

MOUNTAIN VIEW, Calif., March 1 /PRNewswire-FirstCall/ -- VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa, for the... ...

Adventrx Receives Refuse to File Letter from FDA on ANX-530 New Drug Application

Mar 2, 2010 8:17am

SAN DIEGO, March 1 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. announced today that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ANX-530... ...

U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review Omapro

Mar 2, 2010 6:24am

MELBOURNE, Australia & MENLO PARK, Calif.-- Mar 2, 2010 - ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has rescheduled the previously postponed Oncologic Drugs Advisory Committee (ODAC) meeting... ...

FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients

Mar 2, 2010 4:46am

PRINCETON, N.J.--(BUSINESS WIRE)--Mar 2, 2010 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 5 to recommend approval of... ...

Vion Pharmaceuticals Receives Response From FDA on Special Protocol Assessment for Onrigin

Mar 1, 2010 1:12pm

NEW HAVEN, Conn., Feb. 26 /PRNewswire-FirstCall/ -- Vion Pharmaceuticals, Inc. announced today that it had received a response from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment ("SPA") for its oncology therapeutic... ...

FDA Accepts VIAject NDA for Review

Mar 1, 2010 9:52am

DANBURY, Conn.--(BUSINESS WIRE)--Mar 1, 2010 - Biodel Inc. announced today that the U.S. Food and Drug Administration has accepted for review the company's new drug application (NDA) seeking approval to market VIAject for the treatment of... ...

Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA

Feb 26, 2010 5:30am

SAN DIEGO, Feb. 26, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. announced today that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2010, for the review of... ...

Theratechnologies Announces a Tentative New Date for the FDA Advisory Committee Review of the tesamorelin New Drug Application

Feb 25, 2010 5:40am

Montreal, Canada – February 25, 2010 – Theratechnologies (TSX:TH) today announced that the U.S. Food and Drug Administration ("FDA") has set a tentative new date of May 27, 2010 for the Endocrinologic and Metabolic Drugs Advisory Committee... ...

Arena Pharmaceuticals Announces FDA Acceptance of Lorcaserin NDA for Filing

Feb 24, 2010 6:14am

SAN DIEGO, Feb. 24, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. announced today that its New Drug Application (NDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including... ...

Transcept Pharmaceuticals Provides Update on Intermezzo Regulatory Review

Feb 23, 2010 11:14am

POINT RICHMOND, Calif., Feb. 22 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. announced today an update on its plans to seek U.S. Food and Drug Administration (FDA) approval of Intermezzo (zolpidem tartrate sublingual tablet) for... ...

Depomed Comments on DM-1796 Pre-NDA Meeting and Horizant Complete Response Letter

Feb 19, 2010 11:49am

MENLO PARK, Calif.--(BUSINESS WIRE)--Feb 19, 2010 - Depomed, Inc. today announced that it has received final meeting minutes from the FDA for a pre-NDA meeting related to DM-1796 for postherpetic neuralgia (PHN) held in December 2009. Depomed... ...

Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia

Feb 19, 2010 5:00am

PALO ALTO, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment... ...

Alexza Announces AZ-004 (Staccato Loxapine) PDUFA Goal Date of October 11, 2010

Feb 18, 2010 5:58am

MOUNTAIN VIEW, Calif., Feb. 11 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal... ...

GlaxoSmithKline and XenoPort Receive FDA Complete Response Letter for Horizant (GSK1838262/XP13512) for RLS

Feb 18, 2010 5:31am

LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 18, 2010 - GlaxoSmithKline and XenoPort, Inc. (Nasdaq:XNPT) Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding... ...

Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA

Feb 17, 2010 11:54am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 17, 2010 - Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December... ...

CombinatoRx Announces Extension of Exalgo Extended-Release Tablets PDUFA Date to March 1, 2010

Feb 17, 2010 7:51am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 16, 2010 - CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for review of the... ...

Cadence Pharmaceuticals Receives Complete Response Letter from FDA for Intravenous Acetaminophen NDA

Feb 11, 2010 6:37am

SAN DIEGO, Feb. 11 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (NASDAQ:CADX) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for intravenous... ...

XenoPort Announces Extension of the Horizant PDUFA Date to February 11, 2010

Feb 10, 2010 5:35am

SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 9, 2010 - XenoPort, Inc. announced today that the U.S. Food and Drug Administration (FDA) will not be taking an action today on the Horizant (gabapentin enacarbil) new drug application (NDA) for... ...

Biovail Enters into License and Collaboration Agreement with Alexza for AZ-004

Feb 10, 2010 4:34am

TORONTO--(BUSINESS WIRE)--Feb 10, 2010 - Biovail Corporation today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a collaboration and license agreement with Alexza Pharmaceuticals, Inc. BLS has... ...

Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010

Feb 9, 2010 12:55pm

MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--Feb 9, 2010 - ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the Oncologic Drugs Advisory Committee... ...

FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions

Feb 9, 2010 5:48am

SEATTLE, Feb. 9 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration (the "FDA") informed CTI that due to severe weather conditions in the Washington,... ...

Chelsea Therapeutics Announces Advancements in Neurogenic Orthostatic Hypotension Registration Program

Feb 9, 2010 4:58am

CHARLOTTE, N.C., Feb. 9, 2010 -- Chelsea Therapeutics International, Ltd. announced several updates related to its Phase III registration program in neurogenic orthostatic hypotension (NOH), including the selection and preliminary approval by... ...

Repros Submits Response to FDA Regarding Androxal Indication for Treatment of Hypogonadal Men Wishing to Preserve Fertility

Feb 8, 2010 12:45pm

THE WOODLANDS, Texas--(BUSINESS WIRE)--Feb 8, 2010 - Repros Therapeutics Inc. today announced that the Company, as requested by the FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the... ...

XenoPort Announces Horizant as Brand Name for XP13512

Feb 4, 2010 11:31am

SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 4, 2010 - XenoPort, Inc. announced today that, subject to the approval of the U.S. Food and Drug Administration (FDA), the brand name for GSK1838262/XP13512 (gabapentin enacarbil) in the United States... ...

Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious Uveitis

Feb 4, 2010 11:12am

JERSEY CITY, N.J.--(BUSINESS WIRE)--Feb 4, 2010 - Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking... ...

FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review

Feb 2, 2010 11:51am

NDA for Management of Acute Moderate-to-Severe Pain Includes Data from 16 Clinical Studies CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 2, 2010 - Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for... ...

Teva Announces FDA Accepts BLA for XM02

Feb 2, 2010 11:16am

JERUSALEM--(BUSINESS WIRE)--Feb 2, 2010 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva's Biologics License Application (BLA) for XM02, a... ...

Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease

Feb 2, 2010 4:24am

CARMIEL, Israel, Feb. 2 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. (NYSE Amex: PLX) announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the... ...

FDA Extends PDUFA Action Date for Stedesa New Drug Application

Jan 29, 2010 9:56am

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jan 27, 2010 - Sepracor Inc. today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency now anticipates completing its review of the... ...

FDA Issues Complete Response Letter for Low Dose Oral Contraceptive WC 3016

Jan 28, 2010 6:10am

ARDEE, Ireland, Jan. 27 /PRNewswire-FirstCall/ -- Warner Chilcott plc announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) to its New Drug Application submitted in March 2009 for its... ...

Somaxon Provides Update on New Drug Application for Silenor for the Treatment of Insomnia

Jan 25, 2010 10:45am

Resubmission has been filed, with 2 month review cycle SAN DIEGO--(BUSINESS WIRE)--Jan 21, 2010 - Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary... ...

Genzyme's Lumizyme BLA Receives Six-Month FDA Review

Jan 21, 2010 1:11pm

PDUFA Date Set For June 17, 2010 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 21, 2010 - Genzyme Corporation announced today that it has received a June 17, 2010 PDUFA date from the FDA for its Biologics License Application for Lumizyme... ...

MannKind Updates Status of Afrezza New Drug Application

Jan 13, 2010 12:35pm

VALENCIA, Calif.--(BUSINESS WIRE)--Jan 8, 2010 - MannKind Corporation announced that it was informed today by the Food and Drug Administration that the FDA will not be able to complete the review of MannKind's new drug application (NDA) for its... ...

MAP Pharmaceuticals Announces FDA Will Not Require a Second Pivotal Efficacy Study for Levadex NDA Submission

Jan 11, 2010 5:00am

MOUNTAIN VIEW, Calif., Jan. 11 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that a second pivotal efficacy study is not required for the Company's... ...

FDA Grants Priority Review of Pirfenidone NDA for the Treatment of Patients With IPF

Jan 6, 2010 12:25pm

BRISBANE, Calif., Jan 04, 2010 /PRNewswire-FirstCall via COMTEX/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted Priority Review designation for the company's... ...

ADVENTRX Pharmaceuticals Submits ANX-530 New Drug Application

Jan 6, 2010 5:20am

SAN DIEGO, Jan. 4 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530... ...

Dainippon Sumitomo Pharma America Announces the NDA Submission of Lurasidone to the FDA for the Treatment of Schizophrenia

Jan 6, 2010 5:00am

FORT LEE, N.J., Jan. 4 /PRNewswire/ -- Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for... ...

Reports of new drug applications (or withdrawals of such applications) by pharmaceutical companies.

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