Drugs.com - New Drug Applications

AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent

Thu, 19 Nov 2009 13:40:12 GMT

WILMINGTON, Del., Nov. 19 /PRNewswire-FirstCall/ -- AstraZeneca today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the...

NicOx announces FDA accepts naproxcinod NDA for filing

Wed, 18 Nov 2009 13:40:57 GMT

Sophia Antipolis, France, November 18, 2009-NicOx S.A. today announced that it has received a filing communication from the U.S. Food and Drug Administration (FDA) stating that the New Drug Application (NDA) for naproxcinod is accepted for...

Genzyme Receives Complete Response Letter on Lumizyme Application

Tue, 17 Nov 2009 20:15:56 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 16, 2009 - Genzyme Corporation announced today that it has received a complete response letter from the FDA regarding its application to market Lumizyme (alglucosidase alfa) for the treatment of Pompe...

Neuromed Receives FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets

Mon, 16 Nov 2009 20:00:24 GMT

CAMBRIDGE, Mass. & VANCOUVER--(BUSINESS WIRE)--Nov 16, 2009 - CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed...

Human Genome Sciences Receives Complete Response Letter from FDA for Raxibacumab Biologics License Application

Mon, 16 Nov 2009 19:55:43 GMT

ROCKVILLE, Md.--(BUSINESS WIRE)--Nov 16, 2009 - Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company's Biologics...

Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months

Fri, 13 Nov 2009 14:50:42 GMT

SAN DIEGO, Calif., Nov. 13 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the...

ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status

Tue, 10 Nov 2009 13:50:44 GMT

MELBOURNE, Australia, and MENLO PARK, California U.S.A. (10 November 2009) – ChemGenex Pharmaceuticals Limited announced today that the U.S. Food & Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for Omapro...

Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee

Thu, 05 Nov 2009 19:15:46 GMT

Montreal, Canada – November 5, 2009 – Theratechnologies today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration ("FDA") will review Theratechnologies’ NDA for tesamorelin in...

InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF

Wed, 04 Nov 2009 20:51:14 GMT

BRISBANE, Calif., Nov. 4 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the...

FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease

Wed, 04 Nov 2009 14:01:11 GMT

CAMBRIDGE, Massachusetts, November 4/PRNewswire-FirstCall/ -- Shire plc, the global specialty biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug...

GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application

Mon, 02 Nov 2009 14:26:57 GMT

MEMPHIS, Tenn.--(BUSINESS WIRE)--Nov 2, 2009 - GTx, Inc. today announced that it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg...

Dendreon Completes Submission of Biologics License Application for Provenge

Mon, 02 Nov 2009 13:52:17 GMT

SEATTLE, Nov. 2 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that it has completed the submission of the amended Biologics License Application (BLA) for Provenge (sipuleucel-T), the Company's lead investigational product, to the...

Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application

Fri, 30 Oct 2009 13:50:53 GMT

RICHMOND, Calif., Oct. 29 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo (zolpidem...

Gilead's Aztreonam for Inhalation Solution to be Reviewed by FDA Anti-Infective Drugs Advisory Committee on December 10, 2009

Mon, 26 Oct 2009 20:37:26 GMT

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct 26, 2009 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced that aztreonam for inhalation solution, an investigational product for the treatment of infections due to Pseudomonas aeruginosa...

Novartis receives Complete Response letter from FDA for QAB149, an investigational bronchodilator for COPD

Fri, 23 Oct 2009 13:20:44 GMT

* US Food and Drug Administration (FDA) has requested additional information on dosing proposed for QAB149 * Novartis will continue to work with the FDA to gain US approval for QAB149 Basel, October 19, 2009 - Novartis has received a...

Endo Pharmaceuticals Gives Update on Regulatory Status of Fortesta

Thu, 22 Oct 2009 21:10:47 GMT

CHADDS FORD, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for...

Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010

Thu, 22 Oct 2009 13:34:25 GMT

HAWTHORNE, N.Y.--(BUSINESS WIRE)--Oct 22, 2009 - Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR...

Amgen Provides Update on Status of Prolia (denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)

Wed, 21 Oct 2009 19:26:38 GMT

THOUSAND OAKS, Calif., October 19, 2009 /PRNewswire-FirstCall/ -- Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia (denosumab)...

FDA Issues Complete Response Letter for CorVue

Wed, 21 Oct 2009 12:12:30 GMT

BRISTOL, Tenn.--(BUSINESS WIRE)--Oct 21, 2009 - King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for...

Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR

Thu, 15 Oct 2009 00:38:47 GMT

HAWTHORNE, N.Y.--(BUSINESS WIRE)--Oct 14, 2009 - Acorda Therapeutics, Inc. today announced the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on...

Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles

Mon, 12 Oct 2009 13:45:12 GMT

EXTON, Pa., Oct. 9 /PRNewswire/ -- Fibrocell Science, Inc. (OTCBB: FCSC) announced today that the U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee reviewed azfibrocel-T, an autologous cell therapy...

Orexo confirms FDA acceptance of Abstral filing

Tue, 06 Oct 2009 13:46:34 GMT

Uppsala, Sweden, 6th October, 2009 - Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK), has announced that the New Drug Application (NDA) filing for Abstral has been accepted for review by the US Food and Drug...

GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for Votrient

Tue, 06 Oct 2009 00:28:10 GMT

PHILADELPHIA, Oct. 5 /PRNewswire/ -- GlaxoSmithKline [NYSE: GSK] today announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in support of the approval of...

Merck Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States

Fri, 02 Oct 2009 20:12:36 GMT

Darmstadt, September 30, 2009 - Merck KGaA announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, Merck’s proprietary investigational oral formulation of cladribine,...

Discovery Labs and FDA Establish Path for Potential Surfaxin Approval

Fri, 02 Oct 2009 19:39:01 GMT

FDA Supports Proposed BAT Optimization and Approach for Limited Clinical Trial WARRINGTON, Pa., Sept. 30, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) held a teleconference on September 29, 2009 with the U.S. Food and Drug...

Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD

Fri, 02 Oct 2009 12:52:08 GMT

ATLANTA--(BUSINESS WIRE)--Oct 1, 2009 - Sciele Pharma, Inc., a Shionogi company, and Addrenex Pharmaceuticals today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration...

Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients

Tue, 29 Sep 2009 13:11:19 GMT

ATLANTA--(BUSINESS WIRE)--Sep 28, 2009 - Sciele Pharma, Inc., a Shionogi company, today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for glycopyrrolate oral solution to treat...

GSK Provides Update on Regulatory Filings for Zunrisa/Rezonic

Mon, 28 Sep 2009 12:35:59 GMT

LONDON, Sept. 28, 2009--GlaxoSmithKline (GSK) has made the difficult decision to discontinue the regulatory filings for Zunrisa/Rezonic (casopitant), which was being developed for chemotherapy-induced and post-operative nausea and...

NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA

Fri, 25 Sep 2009 13:34:26 GMT

Sophia Antipolis, France, September 25, 2009 – NicOx S.A. today announced that a New Drug Application (NDA) for naproxcinod has been submitted to the United States Food and Drug Administration (FDA), seeking approval for an indication for the...

FDA Advisory Committee Hears Presentations and Public Comment on Exalgo Extended-Release Tablets

Wed, 23 Sep 2009 21:25:39 GMT

ST. LOUIS--(BUSINESS WIRE)--Sep 23, 2009 - Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New...

Savient Provides Update on Meeting with U.S. Food and Drug Administration for Krystexxa

Sat, 19 Sep 2009 13:10:15 GMT

EAST BRUNSWICK, N.J. Sept. 16 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. today announced that on September 14, 2009, the Company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the...

Sanofi-Aventis Receives Complete Response Letter from the FDA for eplivanserin (Ciltyri) Submission

Thu, 17 Sep 2009 14:10:46 GMT

BRIDGEWATER, N.J., Sept. 16 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the company's New Drug Application (NDA) for eplivanserin...

FDA Advisory Committee Unanimously Recommends Approval of Xiaflex for Treatment of Dupuytren's Disease

Thu, 17 Sep 2009 14:10:02 GMT

LYNBROOK, N.Y., Sept. 16 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp., a biopharmaceutical company developing first-in-class collagenase-based products, today announced that the Arthritis Advisory Committee appointed by the U.S....

Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval

Fri, 11 Sep 2009 20:07:58 GMT

WARRINGTON, Pa., Sept. 10, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for September 29, 2009. This meeting will serve...

Merz Pharmaceuticals' Belotero Balance PMA Filing Formally Accepted for Review by the FDA

Fri, 11 Sep 2009 19:27:57 GMT

GREENSBORO, N.C., Sept. 11 /PRNewswire/ -- Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Merz's premarket approval (PMA) application...

FDA Issues Complete Response Letter For Trabectedin Combined With Doxil

Thu, 10 Sep 2009 21:20:57 GMT

HORSHAM, Pa., Sept. 10 /PRNewswire/ -- Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for trabectedin...

FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine

Wed, 09 Sep 2009 20:11:19 GMT

PHILADELPHIA, September 9, 2009 – GlaxoSmithKline announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and...

ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA

Wed, 09 Sep 2009 13:05:51 GMT

MELBOURNE, Australia, and MENLO PARK, California U.S.A. (9th September 2009) – ChemGenex Pharmaceuticals Limited announced today the completion of its New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA) for Omapro...

Archimedes Announces US Filing of NasalFent for the treatment of Breakthrough Cancer Pain

Mon, 07 Sep 2009 13:07:37 GMT

Reading, UK, 7 September 2009 - Archimedes Pharma ("Archimedes"), the pan-European specialty pharmaceutical company, today announced that it has filed a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for its lead...

FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA

Sun, 06 Sep 2009 13:35:34 GMT

SEATTLE, Sept. 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has notified CTI that a Prescription Drug User Fee Act (PDUFA) action date of April...