Drugs.com - New Drug Applications

Ironwood Announces FDA Advisory Committee Meeting Will Not Be Scheduled in Connection with New Drug Application for Linaclotide

Wed, 08 Feb 2012 23:02:14 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 8, 2012 - Ironwood Pharmaceuticals, Inc. announced that it was informed this evening that the U.S. Food and Drug Administration (FDA) will not schedule an advisory committee meeting in connection with...

FDA Grants Genentech's Pertuzumab Priority Review for Previously Untreated HER2-Positive Metastatic Breast Cancer

Tue, 07 Feb 2012 17:02:01 GMT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Feb 7, 2012 - Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application for pertuzumab and...

Salix Pharmaceuticals Announces FDA Granting of Priority Review Designation for the Crofelemer NDA for Treatment of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy

Tue, 07 Feb 2012 12:02:09 GMT

RALEIGH, N.C.--(BUSINESS WIRE)--Feb 7, 2012 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the Company's New Drug Application (NDA)...

Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin

Wed, 01 Feb 2012 21:02:29 GMT

SAN DIEGO, and WOODCLIFF LAKE, N.J., Feb. 1, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified Arena that an Endocrinologic and Metabolic Drugs...

NPS Pharmaceuticals Announces FDA Acceptance of New Drug Application for Gattex (teduglutide) for the Treatment of Adult Short Bowel Syndrome (SBS)

Tue, 31 Jan 2012 13:01:58 GMT

BEDMINSTER, N.J.--(BUSINESS WIRE)--Jan 31, 2012 - NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced the U.S. Food and...

Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph+ Chronic Myeloid Leukemia

Mon, 30 Jan 2012 15:01:54 GMT

NEW YORK--(BUSINESS WIRE)--Jan 27, 2012 - Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for standard review of bosutinib as a treatment option for adult patients with...

Cell Therapeutics Withdraws New Drug Application for Pixuvri and Plans to Resubmit in 2012

Mon, 30 Jan 2012 13:01:01 GMT

SEATTLE, Jan. 30, 2012 /PRNewswire via COMTEX/ --Cell Therapeutics, Inc. ("CTI") announced today that it has voluntarily withdrawn its New Drug Application ("NDA") for Pixuvri (pixantrone) for the treatment of relapsed or refractory aggressive...

Alexza Announces Extension of the Adasuve PDUFA Goal Date by Three Months

Mon, 23 Jan 2012 17:01:45 GMT

MOUNTAIN VIEW, Calif., January 23, 2012, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for...

Bristol-Myers Squibb and AstraZeneca Receive Complete Response Letter from U.S. Food and Drug Administration for Dapagliflozin

Thu, 19 Jan 2012 12:01:31 GMT

PRINCETON, N.J. & WILMINGTON, Del.--(BUSINESS WIRE)--Jan 19, 2012 - AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for...

FDA Accepts Resubmission of Lorcaserin New Drug Application

Tue, 10 Jan 2012 13:01:25 GMT

SAN DIEGO and WOODCLIFF LAKE, N.J., Jan. 10, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has accepted for filing and review Arena's resubmission of the New Drug...

VIVUS Provides Qnexa Regulatory Update

Mon, 09 Jan 2012 12:01:03 GMT

MOUNTAIN VIEW, Calif., Jan. 9, 2012 /PRNewswire/ -- VIVUS, Inc. today announced that following recent discussions with Food and Drug Administration (FDA) officials, the company has been asked to remove the Qnexa contraindication for women...

Chelsea Therapeutics Announces FDA Advisory Committee Meeting Date for Review of Northera NDA for the Treatment of Symptomatic NOH

Thu, 05 Jan 2012 20:01:46 GMT

CHARLOTTE, N.C., Jan. 3, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. announced that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Cardiovascular and Renal Drugs Advisory Committee on...

Arena Submits Response to FDA Complete Response Letter for Lorcaserin

Wed, 04 Jan 2012 15:01:23 GMT

SAN DIEGO and WOODCLIFF LAKE, N.J., Jan. 3, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug...

FDA's Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012

Tue, 03 Jan 2012 12:01:42 GMT

SEATTLE, Jan. 3, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) announced today that on February 9, 2012 the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review CTI's resubmitted New...

ThromboGenics Submits Biologics License Application for Ocriplasmin to the U.S. FDA

Tue, 27 Dec 2011 15:12:13 GMT

LEUVEN, Belgium, December 23, 2011/PRNewswire/ -- ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that it has submitted a Biologics License Application (BLA) with the U.S. Food...

VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity

Tue, 27 Dec 2011 15:12:07 GMT

MOUNTAIN VIEW, Calif., Dec. 23, 2011 /PRNewswire/ -- VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New...

Eisai Resubmits Perampanel (E2007) NDA to FDA

Mon, 26 Dec 2011 23:12:04 GMT

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Dec 26, 2011 - Eisai Inc. announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated...

U.S. FDA Accepts New Drug Application for Gilead's Once-Daily, Single-Tablet Quad HIV Regimen

Sun, 25 Dec 2011 23:12:15 GMT

FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec 23, 2011 - Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen...

Santarus Submits New Drug Application to FDA for Uceris (budesonide) Tablets

Tue, 20 Dec 2011 21:12:23 GMT

SAN DIEGO--(BUSINESS WIRE)--Dec 20, 2011 - Santarus, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking market approval for Uceris (budesonide) Tablets 9 mg for the...

Pfizer Announces FDA Acceptance for Review of New Drug Application for Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis

Tue, 20 Dec 2011 13:12:32 GMT

NEW YORK--(BUSINESS WIRE)--Dec 20, 2011 - Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel,...

FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012

Thu, 15 Dec 2011 20:12:35 GMT

CARMIEL, Israel, Dec. 6, 2011 /PRNewswire/ -- Protalix BioTherapeutics, Inc. announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal...

FDA Grants Priority Review for Kalydeco (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis

Thu, 15 Dec 2011 12:12:13 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 15, 2011 - Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Kalydeco (ivacaftor) and granted the company's...

Salix Pharmaceuticals Announces NDA Submission for Crofelemer for the Treatment of HIV-Associated Diarrhea

Wed, 14 Dec 2011 12:12:44 GMT

RALEIGH, N.C.--(BUSINESS WIRE)--Dec 14, 2011 - Salix Pharmaceuticals, Ltd. today announced that the Company has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Crofelemer for the proposed treatment of...

Tarsa Therapeutics Targets 2012 NDA Submission for its Ostora Oral Calcitonin

Tue, 13 Dec 2011 13:12:50 GMT

PHILADELPHIA, Dec. 13, 2011 /PRNewswire/ -- Tarsa Therapeutics today confirmed that it is planning to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2012 for Ostora, the company's...

FDA Advisory Committee Voted in Favor of Benefit/Risk Profile for Peginesatide for Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

Thu, 08 Dec 2011 13:12:05 GMT

SILVER SPRING, Md. & OSAKA, Japan--(BUSINESS WIRE)--Dec 8, 2011 - Affymax, Inc. and Takeda Pharmaceutical Company Limited, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1,...

FDA Advisory Committee Finds The Benefit/Risk Profile Of Axitinib In Previously Treated Advanced Renal Cell Carcinoma (RCC) To Be Favorable

Wed, 07 Dec 2011 20:12:07 GMT

NEW YORK--(BUSINESS WIRE)--Dec 7, 2011 - Pfizer Inc. announced today that the U.S. Food and Drug Administration's (FDA's) Oncologic Drugs Advisory Committee (ODAC) voted unanimously 13 to 0 that data for the investigational agent axitinib support...

FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone New Drug Application

Tue, 06 Dec 2011 13:12:03 GMT

SEATTLE, Dec. 6, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") today announced that the U.S. Food and Drug Administration's ("FDA") Division of Oncology Products 1 ("DOP1") has notified CTI that CTI's October 2011 resubmitted New Drug...

NPS Pharmaceuticals Completes Submission of New Drug Application for Gattex (teduglutide) in Adult Short Bowel Syndrome (SBS)

Thu, 01 Dec 2011 14:12:32 GMT

BEDMINSTER, N.J.--(BUSINESS WIRE)--Dec 1, 2011 - NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has completed the submission...

Regulatory Update: Glaxosmithkline Submits Additional Information for Candidate Meningococcal and Hib Combination Vaccine

Thu, 01 Dec 2011 14:12:26 GMT

Philadelphia, Pa., Dec. 1, 2011 -GlaxoSmithKline today submitted additional information to the U.S. Food and Drug Administration (FDA) in support of the Biologics License Application (BLA) for the candidate meningococcal and Hib combination...

Onyx Pharmaceuticals Announces FDA Acceptance of New Drug Application for Carfilzomib for the Treatment of Relapsed and Refractory Multiple Myeloma

Tue, 29 Nov 2011 14:11:11 GMT

South San Francisco, CA – November 29, 2011 – Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submission for carfilzomib, a next generation proteasome...

FDA Accepts Eliquis (apixaban) New Drug Application for Review for the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation

Tue, 29 Nov 2011 13:11:17 GMT

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Nov 29, 2011 - Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for Eliquis (apixaban),...

Takeda Submits New Drug Application in the U.S. for Investigational Type 2 Diabetes Therapy, Fixed-Dose Combination Alogliptin/Metformin

Mon, 28 Nov 2011 13:11:46 GMT

OSAKA, Japan and DEERFIELD, Ill., Nov. 23, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug...

U.S. Food and Drug Administration (FDA) Delays Review of Takeda's Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone

Fri, 18 Nov 2011 12:11:31 GMT

FDA assigns new action date of April 25, 2012 for complete review of these filings DEERFIELD, Ill., and OSAKA, Japan, Nov. 18, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Global...

QRxPharma Granted Target Date for FDA Action on MoxDuo IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012

Fri, 11 Nov 2011 21:11:36 GMT

SYDNEY and BEDMINSTER, N.J., Nov. 8, 2011 /PRNewswire/ -- QRxPharma Limited announced today it received written acceptance from the United States Food and Drug Administration (FDA) for review of the MoxDuo IR New Drug Application (NDA) filed...

pSivida Reports Receipt by Alimera Sciences of Complete Response Letter from FDA for Iluvien for DME

Fri, 11 Nov 2011 20:11:02 GMT

WATERTOWN, Mass.--(BUSINESS WIRE)--Nov 11, 2011 - pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today reported that its licensee Alimera Sciences, Inc. (Alimera)...

Receipt of Filing Communication Letter from U.S. FDA Regarding Mirabegron (YM178)

Fri, 11 Nov 2011 15:11:38 GMT

Tokyo, November 11, 2011 - Astellas Pharma Inc. (Tokyo: 4503, “Astellas”) today announced the receipt of a letter from the U.S. Food and Drug Administration (FDA) indicating that it accepted for filing the New Drug Application for mirabegron...

FDA Accepts Genentech's New Drug Application For Vismodegib in Advanced Form of Skin Cancer

Wed, 09 Nov 2011 15:11:15 GMT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov 9, 2011 - Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the company's New Drug Application for vismodegib for the...

Alexza Announces the Adasuve (Staccato Loxapine) PDAC Meeting Date of December 12, 2011

Sun, 06 Nov 2011 23:11:34 GMT

MOUNTAIN VIEW, Calif., Oct. 24, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration (FDA) has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) for December 12,...

FDA Accepts New Drug Application Filing for Qnexa

Thu, 03 Nov 2011 17:11:06 GMT

MOUNTAIN VIEW, Calif., Nov. 3, 2011 /PRNewswire/ -- VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for Qnexa to treat obesity. The company...

Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone

Tue, 01 Nov 2011 13:11:38 GMT

DEERFIELD, Ill., Nov. 1, 2011 /PRNewswire/ -- Takeda Global Research & Development Center, Inc., (Takeda) announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 25,...