Drugs.com - New Drug Applications

Bayer submits first-in-class estradiol-based oral contraceptive for approval in the U.S.

Wed, 08 Jul 2009 13:40:49 GMT

-- FDA approval requested for oral contraception and treatment of heavy and/or prolonged menstrual bleeding Berlin, July 8, 2009 - Bayer has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a new...

Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease

Wed, 08 Jul 2009 01:12:07 GMT

LEXINGTON, Massachusetts, July 6/PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential restriction on the availability of...

Somaxon Announces $6 Million Private Equity Financing and Acceptance of NDA Resubmission of Silenor for the Treatment of Insomnia

Tue, 07 Jul 2009 21:59:07 GMT

SAN DIEGO--(BUSINESS WIRE)--Jul 7, 2009 - Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and...

Acura and King Receive FDA Complete Response Letter Regarding Acurox

Thu, 02 Jul 2009 13:37:45 GMT

PALATINE, Ill. and BRISTOL, Tenn., July 2 /PRNewswire-FirstCall/ -- Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New...

Discovery Labs Reports On Surfaxin End of Review Meeting With FDA

Thu, 02 Jul 2009 13:29:42 GMT

Conference Call Thursday, July 2, 2009 at 8:30 AM EDT WARRINGTON, Pa., July 1, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces today, after receipt of written minutes from the United States Food and Drug...

Photocure submits application for marketing approval for Hexvix in USA to the FDA

Wed, 01 Jul 2009 20:49:53 GMT

Oslo, Norway, 30 June 2009 --Photocure announces today that a New Drug Application (NDA) has been submitted to the US Health Authorities (FDA) to obtain approval for Hexvix for use in the detection of papillary bladder cancer using fluorescence...

Novartis Receives Complete Response Letter From The US Food And Drug Administration For Its Investigational Vaccine Menveo

Wed, 01 Jul 2009 14:44:09 GMT

Cambridge, MA, June 30, 2009 - Novartis Vaccines and Diagnostics received feedback from the US Food and Drug Administration (FDA) in the form of an initial regulatory determination on the Biologics License Application (BLA) for the investigational...

Pozen Submits New Drug Application For Vimovo (PN 400)

Tue, 30 Jun 2009 15:48:30 GMT

CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jun 30, 2009 - Pozen Inc. today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of Vimovo (PN 400), the combination of enteric...

Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

Mon, 29 Jun 2009 00:15:10 GMT

IRVINE, Calif., June 26, 2009 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. today announced the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended the approval of Bepreve...

Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes

Sun, 28 Jun 2009 20:59:56 GMT

DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary...

Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review

Wed, 24 Jun 2009 13:16:50 GMT

Completed NDA submission could lead to marketing approval in Q4-2009 SEATTLE, June 24 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has completed the submission of the New Drug Application...

FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout

Wed, 17 Jun 2009 12:59:18 GMT

EAST BRUNSWICK, N.J., June 16 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. announced today that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a vote of 14 to 1 that Krystexxa...

Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws

Tue, 16 Jun 2009 19:19:32 GMT

PARIS--(BUSINESS WIRE)--Jun 15, 2009 - BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment of cancer and AIDS patients and supportive care, today announced the submission of its New Drug Application (NDA) to the United States...

FDA Extends Review of Arzerra (ofatumumab)

Tue, 16 Jun 2009 12:37:18 GMT

LONDON, June 16, 2009--GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has extended the action date for the ofatumumab BLA application by three...

BioDelivery Sciences Provides NDA Update for Onsolis

Mon, 15 Jun 2009 12:17:29 GMT

RALEIGH, N.C.--(BUSINESS WIRE)--Jun 15, 2009 - BioDelivery Sciences International, Inc. today announced that the company has reached agreement with the U.S. Food and Drug Administration's (FDA) Division of Anesthesia, Analgesia and Rheumatology...

FDA Accepts Final Section of NDA Filing for Lucassin

Fri, 12 Jun 2009 13:44:25 GMT

LEBANON, N.J., and CLINTON, N.J., June 12 /PRNewswire/ -- Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing...

Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo

Thu, 11 Jun 2009 12:25:45 GMT

RICHMOND, Calif., June 11 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension...

NeurogesX Provides U.S. Regulatory Update for Qutenza

Wed, 10 Jun 2009 16:56:19 GMT

SAN MATEO, Calif., June 10, 2009 /PRNewswire-FirstCall/ -- NeurogesX, Inc. announced today that the U.S. Food and Drug Administration (FDA) agreed to its proposed study to evaluate Qutenza in patients with post-herpetic neuralgia (PHN) following...

SkyePharma PLC - Flutiform U.S. Filing Update

Wed, 10 Jun 2009 16:46:08 GMT

LONDON, 9 June 2009 - SkyePharma PLC today announces that the US Food and Drug Administration (FDA) has issued a communication in respect of the New Drug Application (NDA) for its lead development product, Flutiform (fluticasone...

Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema

Mon, 08 Jun 2009 12:44:02 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 8, 2009 - Dyax Corp. (NASDAQ:DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's submission in response to the FDA's March 2009 Complete Response letter...

Somaxon Resubmits New Drug Application for Silenor (Doxepin) for the Treatment of Insomnia

Fri, 05 Jun 2009 18:22:25 GMT

SAN DIEGO--(BUSINESS WIRE)--Jun 4, 2009 - Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product...

Abbott and AstraZeneca Submit New Drug Application to the FDA for Certriad, an Investigational Treatment for Mixed Dyslipidemia

Thu, 04 Jun 2009 15:48:23 GMT

ABBOTT PARK, Ill. and LONDON, June 4 /PRNewswire-FirstCall/ -- Abbott and AstraZeneca announced today that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for...

Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration

Wed, 03 Jun 2009 21:42:07 GMT

MONTREAL, QUEBEC--(Marketwire - June 1, 2009) - Theratechnologies (TSX:TH) today announced that it has filed a New Drug Application ("NDA") with the US Food and Drug Administration ("FDA") for tesamorelin, an analogue of the growth hormone releasing...

Public Citizen: Antiplatelet Medication Is Unsafe, Should Not Be Approved,Says Scientist Who Helped Develop the Drug

Wed, 03 Jun 2009 16:50:29 GMT

Researcher Joins Public Citizen in Asking FDA to Halt Drug Review WASHINGTON, June 3, 2009– One of the scientists who holds a patent application for the blood clot inhibitor prasugrel hydrochloride, an acute coronary syndrome (ACS) treatment,...

Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza (cethromycin)

Wed, 03 Jun 2009 13:29:41 GMT

CHICAGO, June 2 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. announced today that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza(TM) (cethromycin) demonstrated safety for the outpatient...

GE Healthcare's Application for DaTSCAN (Ioflupane I123 Injection) Accepted by the FDA for Priority Review

Tue, 02 Jun 2009 18:19:03 GMT

PRINCETON, N.J.--(BUSINESS WIRE)--Jun 2, 2009 - GE Healthcare announced today that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for DaTSCAN (Ioflupane I123 Injection) for priority review. DaTSCAN is a...

Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency

Tue, 02 Jun 2009 15:37:16 GMT

NESS ZIONA, Israel--(BUSINESS WIRE)--Jun 2, 2009 - Kamada (TASE:KMDA) – a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced that it has submitted a Biologics License...

ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

Tue, 02 Jun 2009 14:43:10 GMT

IRVINE, Calif., June 1 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. today announced it has received notification from the U.S. Food and Drug Administration (FDA) that the Dermatologic and Ophthalmic Drugs Advisory Committee will review...

ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA

Mon, 01 Jun 2009 20:56:14 GMT

BROOMFIELD, Colo.--(BUSINESS WIRE)--Jun 1, 2009 - ARCA biopharma, Inc. (Nasdaq:ABIO) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA, or the Agency) for its New Drug Application (NDA)...

Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA

Mon, 01 Jun 2009 20:44:17 GMT

Submission includes data from three Phase III studies in more than 1,000 patients from 23 countries More than 3 million people in the U.S. are afflicted with epilepsy and seizures1 U.S. epilepsy treatment market estimated to be $3.5 billion2...

Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza (cethromycin)

Fri, 29 May 2009 19:50:28 GMT

CHICAGO, May 29 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the June 2, 2009 Anti-Infective Drugs Advisory...

GSK/Genmab Receive Favorable Recommendation for Arzerra from FDA Advisory Panel

Fri, 29 May 2009 19:15:05 GMT

ORLANDO, FL, May 29, 2009 – GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the Arzerra (ofatumumab) data are reasonably...

U.S. FDA Issues Complete Response Letter for Rivaroxaban

Thu, 28 May 2009 16:58:09 GMT

Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: U.S. FDA Issues Complete Response Letter for Rivaroxaban No new clinical or non-clinical studies to be conducted as a pre-requisite for approval LEVERKUSEN, Germany, May 28, 2009 -...

Warner Chilcott Announces FDA Acceptance of NDA Submission for Low Dose Oral Contraceptive

Wed, 27 May 2009 19:56:23 GMT

ARDEE, Ireland, May 27 /PRNewswire-FirstCall/ -- Warner Chilcott Limited announced today that the U.S. Food and Drug Administration (FDA) has filed for standard review the new drug application (NDA) for WC 3016, a low dose oral contraceptive. The...

FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months

Wed, 27 May 2009 14:50:31 GMT

HORSHAM, Pa., May 26 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for Stelara (ustekinumab)...

PharmAthene Submits SparVax Regulatory Strategy to FDA

Tue, 26 May 2009 15:33:32 GMT

ANNAPOLIS, Md., May 22 /PRNewswire-FirstCall/ -- PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, today announced that the Company has submitted its comprehensive regulatory strategy...

Skyepharma plc: Flutiform NDA Accepted for Review

Fri, 22 May 2009 13:28:34 GMT

LONDON, 22 May 2009 - SkyePharma PLC today announces that the New Drug Application (NDA) for its lead development product, Flutiform (fluticasone propionate/formoterol fumarate), an investigational treatment for persistent asthma in patients 12...

Genzyme Submits All Information Requested by FDA for Lumizyme

Thu, 21 May 2009 18:41:52 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 21, 2009 - Genzyme Corporation announced today that it has submitted the final documentation to address all items in the FDA's complete response letter for Lumizyme (alglucosidase alfa), produced at the 2,000 L...

Human Genome Sciences Submits Biologics License Application to FDA for ABthrax

Thu, 21 May 2009 13:55:49 GMT

ROCKVILLE, Md., May 21 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its human monoclonal antibody drug ABthrax...

Emisphere Technologies Receives Milestone Payment from MannKind Corporation

Thu, 21 May 2009 13:54:40 GMT

CEDAR KNOLLS, N.J.--(BUSINESS WIRE)--May 21, 2009 - Emisphere Technologies, Inc. today announced that it has received a $500,000 milestone payment from MannKind Corporation in connection with MannKind's recent filing and the U.S. Food & Drug...