Drugs.com - New Drug Applications

New Drug Application Submitted For Acurox Tablets

Fri, 02 Jan 2009 13:45:07 GMT

Opioid Analgesic Product Designed to Deter Prescription Drug Abuse PALATINE, Ill. and BRISTOL, Tenn., Jan. 2, 2009 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. today announced that Acura has submitted a New Drug...

FDA Cardio Renal Advisory Committee to Review Daiichi Sankyo, Lilly Drug Prasugrel

Wed, 31 Dec 2008 13:24:47 GMT

TOKYO and INDIANAPOLIS, December 31, 2008 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited and Eli Lilly and Company today confirmed that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee...

King Pharmaceuticals Provides Update on Embeda NDA Review

Wed, 31 Dec 2008 13:11:43 GMT

BRISTOL, Tenn.--(BUSINESS WIRE)--Dec 31, 2008 - King Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) is continuing its review of the New Drug Application (NDA) for Embeda (morphine sulfate and naltrexone...

BLA for PolyHeme Accepted for Filing and Granted Priority Review

Tue, 30 Dec 2008 14:10:22 GMT

EVANSTON, Ill.--(BUSINESS WIRE)--Dec 30, 2008 - Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for PolyHeme, the Company's...

Pegloticase BLA Filing Accepted for Priority Review by FDA

Tue, 30 Dec 2008 13:25:05 GMT

EAST BRUNSWICK, N.J., December 29, 2008 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for...

FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application

Mon, 29 Dec 2008 18:34:10 GMT

PARIS--(BUSINESS WIRE)--Dec 29, 2008 - Regulatory News: Ipsen today announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport. The...

Takeda Receives New Action Date for Alogliptin (SYR-322) NDA

Wed, 24 Dec 2008 14:33:32 GMT

OSAKA, Japan, December 24, 2008 - 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 that the U.S. Food and...

AMAG Pharmaceuticals Receives Complete Response Letter from the FDA for Ferumoxytol

Tue, 23 Dec 2008 12:34:05 GMT

Also Announces Feraheme Trade Name LEXINGTON, Mass.--(BUSINESS WIRE)--Dec 23, 2008 - AMAG Pharmaceuticals, Inc. today announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ferumoxytol for the...

Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer

Mon, 22 Dec 2008 12:53:28 GMT

THOUSAND OAKS, Calif., Dec. 19 /PRNewswire-FirstCall/ -- Amgen Inc. today announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for denosumab, an investigational RANK Ligand inhibitor. The...

King Pharmaceuticals Announces Submission of New Drug Application for CorVue

Fri, 19 Dec 2008 16:05:12 GMT

BRISTOL, Tenn.--(BUSINESS WIRE)--Dec 18, 2008 - King Pharmaceuticals, Inc. today announced it has submitted a New Drug Application (NDA) for CorVue (binodenoson) for injection to the U.S. Food and Drug Administration (FDA). CorVue is a cardiac...

FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application

Fri, 19 Dec 2008 15:17:47 GMT

HORSHAM, Pa., December 19, 2008 /PRNewswire/ -- Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab. The application, filed by...

NeurogesX Announces FDA Acceptance to Review New Drug Application for NGX-4010 to Treat Post-Herpetic Neuralgia

Fri, 19 Dec 2008 14:10:11 GMT

SAN MATEO, Calif., December 19, 2008 /PRNewswire-FirstCall/ -- NeurogesX, Inc. , a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that the U.S. Food and Drug Administration (FDA)...

Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo

Tue, 16 Dec 2008 18:32:43 GMT

FDA to review Intermezzo (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings PT. RICHMOND, Calif., Dec. 16 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a...

BioDelivery Sciences Submits REMS for Onsolis to FDA for Approval

Mon, 15 Dec 2008 20:05:42 GMT

First Half 2009 Approval Still Anticipated RALEIGH, N.C.--(BUSINESS WIRE)--Dec 15, 2008 - BioDelivery Sciences International, Inc. announced that it has resubmitted its New Drug Application (NDA) for the company's lead product Onsolis to the Food...

Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia

Fri, 12 Dec 2008 13:08:06 GMT

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Dec 11, 2008 - Genta Incorporated announced that the Company has filed an appeal of the recent negative decision by the Food and Drug Administration's (FDA) Office of Oncology Drug Products (OODP) regarding...

Barr's BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for Filing by FDA

Thu, 11 Dec 2008 16:55:57 GMT

MONTVALE, N.J., December 11, 2008--/PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral...

Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy

Thu, 11 Dec 2008 14:15:35 GMT

SAN MATEO, Calif., December 11, 2008 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Remoxy, an abuse-resistant...

Acusphere Announces Results of FDA Advisory Committee Meeting

Thu, 11 Dec 2008 13:00:11 GMT

WATERTOWN, Mass.--(BUSINESS WIRE)--Dec 11, 2008 - Acusphere, Inc. today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using...

FDA Issues Complete Response Letter for Oritavancin

Tue, 09 Dec 2008 13:05:39 GMT

FDA Requests Additional Phase 3 Clinical Study Prior to Approval CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 9, 2008 - Targanta Therapeutics Corporation (Nasdaq: TARG) announced today that it has received a Complete Response Letter from the U.S. Food...

Marketing Authorization Application for Lipsovir Now Validated by American and European Regulatory Authorities

Mon, 08 Dec 2008 19:50:10 GMT

HUDDINGE, Sweden, Dec. 8, 2008--Medivir announced today that the American (FDA) and European regulatory authorities have validated the NDA and Marketing Authorization Application for Lipsovir. The authorities will start the review process to...

Acusphere, Inc. Announces Posting of Briefing Documents for FDA Cardio Renal Drugs Advisory Committee Meeting on Imagify

Mon, 08 Dec 2008 15:20:59 GMT

WATERTOWN, Mass.--(BUSINESS WIRE)--Dec 8, 2008 - Acusphere, Inc. today announced that the U.S. Food & Drug Administration (FDA) has posted briefing documents on its website for the December 10 Cardio Renal Advisory Committee (CRAC) Meeting. The CRAC...

Alfacell Provides Onconase NDA Submission Update

Mon, 08 Dec 2008 13:20:38 GMT

SOMERSET, N.J., December 05, 2008 /PRNewswire-FirstCall/ -- Alfacell Corporation today reported that the U.S. Food and Drug Administration (FDA) has scheduled a pre-NDA meeting date at the end of January 2009 for discussion of the company's planned...

FDA Advisory Committee Unanimously Recommends Approval of Latisse (Bimatoprost Solution 0.03%) as a Treatment for Hypotrichosis of Eyelashes

Mon, 08 Dec 2008 13:15:58 GMT

IRVINE, Calif.--(BUSINESS WIRE)--Dec 5, 2008 - Allergan, Inc. today announced the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (9-0) to recommend that the FDA approve Latisse...

Erbitux Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted to U.S. Food and Drug Administration

Mon, 08 Dec 2008 05:00:00 GMT

NEW YORK--(BUSINESS WIRE)--Dec 8, 2008 - ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, and Bristol-Myers Squibb Company today announced that they have submitted an application to the U.S. Food and Drug Administration (FDA) to...

FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop

Fri, 05 Dec 2008 15:50:21 GMT

ROCHESTER, N.Y.--(BUSINESS WIRE)--Dec 5, 2008 - The U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee today voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension,...

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...