BioSpace.com News

Alimera Sciences Announces New PDUFA Date for ILUVIEN??

Wed, 01 May 2013 12:00:00 AM GMT

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ATLANTA, May 1, 2013 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that...

QRxPharma Pty Ltd. Sets PDUFA Date for MOXDUO® NDA

Thu, 14 Mar 2013 12:00:00 AM GMT

SYDNEY and BEDMINSTER, N.J., March 14, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 26 August 2013 as the Prescription Drug User Fee Act (PDUFA) date for action on the Company's resubmitted MOXDUONew Drug...

Hyperion Therapeutics Notified That FDA Will Not Meet the PDUFA Action Date for Ravicti™

Wed, 16 Jan 2013 12:00:00 AM GMT

SOUTH SAN FRANCISCO, Calif., Jan. 16, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) said that the U.S. Food and Drug Administration (FDA) has advised the Company not to expect a final action by the Prescription Drug User Fee Act (PDUFA) action date of January 23, 2013. The agency explained it is continuing to work on label and post-marketing requirements in connection with Hyperion...

Pfizer Inc./Ligand Pharmaceuticals Inc. Get PDUFA Date for Menopause Combo

Fri, 14 Dec 2012 12:00:00 AM GMT

NEW YORK & SAN DIEGO--(BUSINESS WIRE)-- Pfizer Inc. (PFE) and Ligand Pharmaceuticals Incorporated (LGND) today announced that the United States Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar...

Aegerion Pharmaceuticals, Inc. Soars as FDA Panel Backs Cholesterol Drug

Fri, 19 Oct 2012 12:00:00 AM GMT

CAMBRIDGE, Mass., Oct. 17, 2012 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (AEGR), an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat debilitating and often fatal rare diseases, announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) determined by a vote...

FDA Extends Review of Biogen Idec, Inc. (Massachusetts) MS Drug

Thu, 18 Oct 2012 12:00:00 AM GMT

WESTON, Mass.--(BUSINESS WIRE)-- Today Biogen Idec (BIIB) announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the New Drug Application (NDA) for the marketing approval of BG-12 (dimethyl fumarate), the companys oral therapeutic candidate for the treatment of multiple sclerosis (MS). The 3 month extension is a standard extension period....

A.P. Pharma, Inc. Announces PDUFA Action Date for APF530 New Drug Application Resubmission

Tue, 16 Oct 2012 12:00:00 AM GMT

REDWOOD CITY, Calif.--(BUSINESS WIRE)--A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Companys resubmission of its New Drug Application (NDA) for APF530. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2013. APF530 is a long-acting formulation of granisetron and...

Impax Pharmaceuticals: FDA Extends Review on Rytary NDA

Fri, 12 Oct 2012 12:00:00 AM GMT

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (IPXL) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the RytaryTM (IPX066) New Drug Application (NDA) from October 21, 2012, to January 21, 2013.

The FDA notified Impax that its...

GlaxoSmithKline, Theravance, Inc.: FDA OK for FF/VI

Thu, 27 Sep 2012 12:00:00 AM GMT

LONDON and SOUTH SAN FRANCISCO, Calif., Sept. 26, 2012 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (GSK) and Theravance, Inc. (THRX) today announced that the New Drug Application (NDA) for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" (FF/VI) for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the US Food and Drug Administration (FDA...

Hyperion Therapeutics Announces Extension of Action Date for Ravicti™ NDA to January 23, 2013

Thu, 06 Sep 2012 12:00:00 AM GMT

SOUTH SAN FRANCISCO, Calif., Sept. 5, 2012 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) announced today that it has received a communication from the U.S. Food and Drug Administration (FDA) extending the Prescription Drug User Fee Act (PDUFA) action date for its New Drug Application (NDA) for Ravicti (glycerol phenylbutyrate) by three months to January 23, 2013. The FDA extended the...

Medivation, Inc. and Astellas Pharma Inc. Get PDUFA Date for Prostate Cancer Drug

Mon, 06 Aug 2012 12:00:00 AM GMT

SAN FRANCISCO, CA and TOKYO--(Marketwire - August 03, 2012) - Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012 for the review of the investigational...

FDA Grants Priority Review for Exelixis, Inc.'s Cabozantinib in Medullary Thyroid Cancer

Mon, 30 Jul 2012 12:00:00 AM GMT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). The FDA also granted priority review designation to the NDA for cabozantinib...

Alexza Pharmaceuticals, Inc. Announces Adasuve PDUFA Goal Date Of Dec. 21, 2012

Fri, 06 Jul 2012 12:00:00 AM GMT

MOUNTAIN VIEW, Calif., July 5, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company's resubmitted ADASUVE New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date...

Consumer Group Urges FDA to Reject Arena Pharmaceuticals, Inc. Diet Drug

Thu, 28 Jun 2012 12:00:00 AM GMT

Watchdog group Public Citizen urged U.S. regulators on Tuesday not to approve Arena Pharmaceuticals Inc's experimental diet pill lorcaserin, citing concerns it could increase patients' risk of heart valve damage. The U.S. Food and Drug Administration is expected to rule on whether to approve the drug by Wednesday. Public Citizen, a nonprofit consumer advocacy group, said physicians at last month's...

Eli Lilly and Company Statement on PDUFA Vote by Senate

Wed, 27 Jun 2012 12:00:00 AM GMT

INDIANAPOLIS, June 26, 2012 /PRNewswire/ -- Following is a statement from John C. Lechleiter, Ph.D., chairman, president, and chief executive officer of Eli Lilly and Company (NYSE: LLY), regarding today's Senate vote on S.3187 to reauthorize the Prescription Drug User Fee Act...

If Arena Pharmaceuticals, Inc.'s Lorcaserin is Approved, Buy VIVUS, Inc.

Wed, 27 Jun 2012 12:00:00 AM GMT
There are conflicting messages coming out of recent FDA advisory panels. On March 29, 2012, an Endocrinologic and Metabolic Drugs Advisory Committee voted to require cardiovascular outcome trials (CVOT) using major cardiovascular events (MACE) as the primary endpoint. But on May 10, 2012, another Endocrinologic and Metabolic Drugs Advisory voted 18-4-1 in favor of approval of Arena's (ARNA) obesity...

FDA Receives Repros Therapeutics Inc.' Submission for Special Protocol Assessment Documentation for Pivotal Studies for Androxal(R)

Thu, 17 May 2012 12:00:00 AM GMT
THE WOODLANDS, Texas, May 16, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. (Nasdaq:RPRX) today announced it has received confirmation of delivery of the required documentation for Special Protocol Assessment ("SPA") of its Androxal Phase 3 pivotal studies to the FDA. Per the Prescription Drug User Fee Act ("PDUFA"), the FDA has 45 calendar days to provide comments back to Repros.

Arena Pharmaceuticals, Inc. Wins Positive FDA Panel Vote for Obesity Drug

Mon, 14 May 2012 12:00:00 AM GMT
WOODCLIFF LAKE, N.J., May 10, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks...

Gilead Sciences, Inc.'s Pill Wins U.S. Panel Backing to Prevent HIV

Fri, 11 May 2012 12:00:00 AM GMT
FOSTER CITY, Calif., May 10, 2012 (BUSINESS WIRE) -- Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure...

Talon Therapeutics, Inc. Receives Notification of Three Month PDUFA Date Extension for Marqibo(R)

Tue, 08 May 2012 12:00:00 AM GMT
SAN MATEO, Calif., May 7, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics Inc., (OTCBB:TLON), today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) seeking accelerated approval of Marqibo has been given a three-month Prescription Drug User Fee Act (PDUFA) date extension to August 12, 2012.
On March 21, 2012, the Oncologic...

Napo Pharmaceuticals, Inc. Comments on FDA Announcing Extension of Crofelemer NDA Priority Review

Fri, 04 May 2012 12:00:00 AM GMT
SAN FRANCISCO--(BUSINESS WIRE)-- Napo Pharmaceuticals, Inc. (Napo) has been informed that the U.S. Food & Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for the companys first in class novel drug compound, crofelemer. The Agencys Priority Review of the New Drug Application (NDA) for crofelemer is for the indication of chronic diarrhea in people living with...

Navidea Biopharmaceuticals Release: FDA Extends PDUFA Date for Lymphoseek?? by Three

Tue, 03 Apr 2012 12:00:00 AM GMT
DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB) today announced that yesterday it received notification from the United States Food and Drug Administration (FDA) that the Prescription Drug User Fee Act (PDUFA) date for 99m-Tc-Tilmanocept (Lymphoseek), has been modified to September 10, 2012, a 90-day extension from the initial PDUFA date of June 10th. Lymphoseek is...

Talon Therapeutics, Inc.' Marqibo(R) Wins Backing of FDA Advisory Panel

Fri, 23 Mar 2012 12:00:00 AM GMT
SAN MATEO, Calif., Mar 21, 2012 (GlobeNewswire via COMTEX) -- Talon Therapeutics, Inc., announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit/risk assessment for use of Marqibo(R) (vincristine sulfate liposomes injection) seeking the indication for the treatment of adult Philadelphia chromosome-negative (Ph...

Napo Pharmaceuticals, Inc. Release: FDA Grants PDUFA Date of June 5, 2012 for Crofelemer

Wed, 08 Feb 2012 12:00:00 AM GMT
SAN FRANCISCO--(BUSINESS WIRE)--Napo Pharmaceuticals, Inc. (Napo) announced today that the New Drug Application (NDA) submitted on December 5, 2011 for crofelemer for the indication of chronic diarrhea in people living with HIV/AIDS on anti-retro viral therapy (CRO-HIV) was accepted for filing by the U.S. Food and Drug Administration (FDA) with a Priority Review designation. The FDA has set...

Talon Therapeutics, Inc.' Product Candidate Marqibo(R) to be Assessed by Oncologic Drug Advisory Committee (ODAC) on March 21, 2012 With a PDUFA Date of May 13, 2012

Fri, 03 Feb 2012 12:00:00 AM GMT
SAN MATEO, Calif., Feb. 3, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics Inc. (OTCBB:TLON) announced Marqibo (vincristine sulfate liposomes injection) is scheduled to be assessed by ODAC on Wednesday, March 21, 2012. Talon's New Drug Application (NDA) for Marqibo was accepted for filing by the FDA and is being reviewed under Subpart H Accelerated Approval of New Drugs for Serious or Life Threatening...

Alexza Pharmaceuticals, Inc. Announces Extension of the ADASUVE??? PDUFA Goal Date by Three Months

Mon, 23 Jan 2012 12:00:00 AM GMT
MOUNTAIN VIEW, Calif., Jan. 23, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) 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 ADASUVE (Staccato loxapine).
In a notice received from the FDA, the Prescription Drug...

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

Tue, 06 Dec 2011 12:00:00 AM GMT
SEATTLE, Dec. 6, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) 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 Application ("NDA") is considered a complete, Class 2 response to the...

FDA Extends Protalix Biotherapeutics, Inc.'s Taliglucerase Alfa PDUFA Date to May 1, 2012

Tue, 06 Dec 2011 12:00:00 AM GMT
CARMIEL, Israel, Dec. 6, 2011 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), 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 date of the New Drug Application (NDA) for taliglucerase alfa to...

FDA Delays Review of Takeda Pharmaceutical Co. Ltd.'s Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone

Fri, 18 Nov 2011 12:00:00 AM GMT
DEERFIELD, Ill., and OSAKA, Japan, Nov. 18, 2011 /PRNewswire via COMTEX/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the...

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

Tue, 08 Nov 2011 12:00:00 AM GMT
SYDNEY and BEDMINSTER, N.J., Nov. 8, 2011 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) 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 earlier this year. The FDA also set June...

FDA Revises IntelGenx Corp.' CPI-300 PDUFA Date to November 10th

Mon, 07 Nov 2011 12:00:00 AM GMT
SAINT LAURENT, Quebec, Nov. 7, 2011 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCBB:IGXT) ("IntelGenx") today announced that the U.S. Food and Drug Administration ("FDA") has revised the CPI-300 Prescription Drug User Fee Act ("PDUFA") date to November 10th, 2011 from their previous guidance of November 13th, 2011. CPI-300 is a novel, high strength of Bupropion Hydrochloride (HCl), the active...

Takeda Global Research & Development Center, Inc. Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone

Tue, 01 Nov 2011 12:00:00 AM 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, 2012 for the review of its investigational type 2 diabetes therapy alogliptin...

FDA Delays Ruling on Bristol-Myers Squibb Company, AstraZeneca PLC Diabetes Drug

Fri, 28 Oct 2011 12:00:00 AM GMT
PRINCETON, N.J. & WILMINGTON, Del.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for dapagliflozin for the treatment of type 2 diabetes by three months. The new Prescription Drug User Fee Act (PDUFA) goal date is January 28, 2012.
Bristol-Myers Squibb and...

Biogen Idec, Inc. (Massachusetts) and Elan Corporation PLC Receive Notification of PDUFA Date Extension

Thu, 20 Oct 2011 12:00:00 AM GMT
WESTON, Mass. & DUBLIN--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the supplemental Biologics License Application (sBLA) for TYSABRI (natalizumab). The sBLA was submitted in December 2010 to update the Prescribing Information for TYSABRI to include...

Transcept Pharmaceuticals, Inc. Shares Soar on Potential Sleeping Pill Approval; Intermezzo(R) PDUFA Action Date of November 27, 2011

Wed, 05 Oct 2011 12:00:00 AM GMT
RICHMOND, Calif., Oct. 4, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that it has classified the recent Intermezzo New Drug Application (NDA) resubmission as a complete Class 1 response. The FDA has assigned a Prescription Drug User Fee Act ...

Discovery Laboratories Notified of PDUFA Date for SURFAXIN(R)

Wed, 28 Sep 2011 12:00:00 AM GMT

WARRINGTON, Pa., Sept. 28, 2011 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO) announced today that the U.S. Food and Drug Administration (FDA) has deemed "complete" the company's Complete Response for SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants...

Amgen: FDA to Decide on New Xgeva Use by April

Fri, 26 Aug 2011 12:00:00 AM GMT

THOUSAND OAKS, Calif., Aug. 22, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) to...

Alexza Pharmaceuticals, Inc. Announces Adasuve (Staccato(R) Loxapine) PDUFA Goal Date of February 4, 2012

Fri, 19 Aug 2011 12:00:00 AM GMT
MOUNTAIN VIEW, Calif., Aug. 19, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food & Drug Administration (FDA) has accepted the ADASUVE New Drug Application (NDA) as a complete, class 2 response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of

Affymax, Inc. Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application

Thu, 11 Aug 2011 12:00:00 AM GMT
PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq: AFFY) today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012 for the review of the investigational agent peginesatide (formerly known as Hematide) New Drug Application (NDA). The company had announced on July 27, 2011 that the FDA accepted the peginesatide...

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes's BYDUREON Reply Submitted to FDA

Mon, 01 Aug 2011 12:00:00 AM GMT
July 28, 2011/PRNewswire/ --Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON (exenatide extended-release...

FDA Delays Decision on Pacira Pharmaceuticals, Inc.'s Exparelf

Tue, 14 Jun 2011 12:00:00 AM GMT

PARSIPPANY, N.J., June 14, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc., (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application...

IntelGenx Corp. Announces New PDUFA Date for Its Single Dose 450 mg Bupropion Hydrochloride Tablet

Tue, 14 Jun 2011 12:00:00 AM GMT
SAINT LAURENT, QUEBEC--(Marketwire - 06/14/11) - IntelGenx Corp. (TSX-V:IGX - News)(OTC.BB:IGXT - News) ("IntelGenx", or "the Company"), announced that the U.S. Food and Drug Administration ("FDA") has accepted the Company's resubmission of its antidepressant CPI-300 New Drug Application 505(b)(2) in response to the February 2010 Complete Response Letter ("CRL") as a complete, Class 2 response. In...

Lannett Company, Inc. Announces Revised FDA PDUFA Date for Morphine Sulfate Oral Solution NDA

Tue, 07 Jun 2011 12:00:00 AM GMT
PHILADELPHIA--(BUSINESS WIRE)-- Lannett Company, Inc. (NYSE AMEX: LCI) announced today that the U.S. Food and Drug Administration (FDA) has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011 for the companys 505(b)(2) New Drug Application for Morphine Sulfate Oral Solution.
With a revised PDUFA date in 17 days, we are preparing for the re-launch of our Morphine...

Labeling and Script Use May Cause Problems For Optimer Pharmaceuticals, Inc.'s New Drug

Fri, 27 May 2011 12:00:00 AM GMT
Optimer Pharmaceuticals (OPTR) is quickly approaching its May 30 PDUFA as as heavy favourite to win a positive vote from the FDA to market its product, yet it seems that many investors are discounting the potential for a surprise negative outcome.
The company is trying to obtain approval for its flagship product, fidaxomicin which could make it the first Clostridium defficile infection ...

INSYS Therapeutics Announces NDA PDUFA Date for Fentanyl SL Spray

Mon, 23 May 2011 12:00:00 AM GMT
INSYS Therapeutics, Inc. (formerly NeoPharm, Inc.) (Other OTC:NEOL) today announced that the U.S. Food and Drug Administration (FDA) has provided an anticipated Prescription Drug User Fee Act (PDUFA) goal date of January 4, 2012 for its review of the New Drug Application (NDA) for Fentanyl SL Spray.
We look forward to working with the FDA during the review process and, if approved, making...

Seattle Genetics, Inc. Announces FDA Accepts Brentuximab Vedotin BLA; PDUFA Date Set for August 30, 2011

Mon, 02 May 2011 12:00:00 AM GMT
BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing two Biologics License Applications (BLAs) for brentuximab vedotin, including one for the treatment of patients with relapsed or refractory Hodgkin lymphoma and one for the treatment of patients with relapsed or refractory systemic anaplastic...

Optimer Pharmaceuticals, Inc. Wins FDA Advisory Panel's Backing for Fidaxomicin for Treatment of Patients With Clostridium difficile Infection (CDI)

Thu, 07 Apr 2011 12:00:00 AM GMT
Optimer to host conference call for investors on April 6 at 8:00 a.m. Eastern Time
San Diego, CA April 5, 2011 Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administrations (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) recommended that the FDA approve Optimers investigational antibiotic DIFICID (fidaxomicin) for the treatment of patients...

FDA Accepts for Review Spectrum Pharmaceuticals, Inc.???s ZEVALIN(R) Submission for the Removal of the Bioscan; Establishes PDUFA Date

Tue, 22 Mar 2011 12:00:00 AM GMT
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement containing data providing for the removal of the Indium-111 ZEVALIN (ibritumomab...

FDA Assigns PDUFA Date for s FIRAZYR(R) (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema

Mon, 21 Mar 2011 12:00:00 AM GMT
DUBLIN and LEXINGTON, Massachusetts, March 21, 2011 /PRNewswire-FirstCall/ -- Shire plc (LSE:SHP.l - News), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of August 25, 2011 for the review of the New Drug Application (NDA) for FIRAZYR(R) (icatibant) for the treatment of acute attacks...

US FDA Assigns New PDUFA Date for AstraZeneca PLC's BRILINTA (ticagrelor tablets)

Fri, 04 Feb 2011 12:00:00 AM GMT
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca (NYSE:AZN - News) announced today that the US Food and Drug Administration (FDA) has acknowledged receipt of the companys reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA). Accordingly, the agency has accepted AstraZenecas resubmission of the ticagrelor NDA, categorized it as a Class 2 resubmission to the CRL...

Transcept Pharmaceuticals, Inc. Announces Intermezzo(R) PDUFA Action Date of July 14, 2011

Mon, 31 Jan 2011 12:00:00 AM GMT
RICHMOND, Calif., Jan. 31, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that the U.S. Food and Drug Administration (FDA) has classified the recent Intermezzo New Drug Application (NDA) resubmission as a complete Class 2 response and assigned a Prescription Drug User Fee Act (PDUFA) action date of

DURECT Corporation, King Pharmaceuticals??, Inc.'s REMOXY(R) New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011

Thu, 27 Jan 2011 12:00:00 AM GMT
CUPERTINO, Calif., Jan. 27, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today reported that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for REMOXY by King Pharmaceuticals, Inc. (NYSE: KG) and the PDUFA goal date is June 23, 2011.
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ADVENTRX Pharmaceuticals Inc. Receives PDUFA Date for Exelbine NDA

Wed, 19 Jan 2011 12:00:00 AM GMT
SAN DIEGO, Jan. 19, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA). The acceptance of the Exelbine NDA is the FDA's determination that the application is sufficiently...

KV Pharmaceutical Company Updates Status of New Drug Application for Gestiva(TM); FDA Extends PDUFA Date to April 13, 2011

Wed, 12 Jan 2011 12:00:00 AM GMT
ST. LOUIS, Jan. 12, 2011 /PRNewswire/ -- K-V Pharmaceutical Company (NYSE: KVa/KVb) today issued an update on the status of the U.S. Food and Drug Administration's review of Hologic, Inc.'s (Hologic) New Drug Application (NDA) for Gestiva (hydroxyprogesterone caproate injection) as a treatment for the prevention of preterm birth in women with a singleton pregnancy...

FDA Delays PDUFA On Human Genome Sciences, Inc. and GlaxoSmithKline Lupus Drug Benlysta

Tue, 07 Dec 2010 12:00:00 AM GMT
Pharmaceutical Business Review -- The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of Human Genome Sciences (HGS) and GlaxoSmithKline's (GSK) biologics license application (BLA) for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from 9 December 2010 to 10 March 2011.

FDA Accepts for Review Spectrum Pharmaceuticals, Inc.???s Response on FUSILEV(R) as a Class 2 Submission, and Establishes April 29, 2011 as PDUFA Action Date

Mon, 29 Nov 2010 12:00:00 AM GMT
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGM:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin...

Salix Pharmaceuticals, Ltd. Says FDA Extends Review of Bowel Syndrome Drug; PDUFA Goal Date Extended by 3 Months

Mon, 04 Oct 2010 12:00:00 AM GMT
Oct. 4, 2010 (Business Wire) -- Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agencys Priority Review of the efficacy supplement to NDA 21-361 for XIFAXAN (rifaximin) 550 mg Tablets for the proposed indication of the treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related...

Endo Pharmaceuticals Receives FDA Priority Review for New Formulation of Long-Acting Oxymorphone Designed to be Crush Resistant; PDUFA Date Set for January 7

Wed, 22 Sep 2010 12:00:00 AM GMT

CHADDS FORD, Pa., Sept. 22 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that Endo's new drug application (NDA) for its new oral formulation of long-acting oxymorphone, which is designed to be crush...

Questcor Pharmaceuticals, Inc. (Headquarters) Says FDA To Take More Time To Review Label Wording for Acthar

Thu, 09 Sep 2010 12:00:00 AM GMT
Sept 8 (Reuters) - Questcor Pharmaceuticals Inc (QCOR.O) said U.S. health regulators extended, for the second time, review of the company's Acthar gel to treat seizures in infants.

GlaxoSmithKline, Valeant Pharmaceuticals International Face US Delay for Epilepsy Drug, Receives New PDUFA Date

Tue, 31 Aug 2010 12:00:00 AM GMT
LONDON, RESEARCH TRIANGLE PARK, N.C., and ALISO VIEJO, Calif., Aug. 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:GSK - News) and Valeant Pharmaceuticals International (NYSE:VRX - News) announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine* to 30 November 2010. The original goal date was 30 August 2010.
...

FDA Panel To Vet Boehringer Ingelheim Corporation Blood Thinner September 20

Thu, 26 Aug 2010 12:00:00 AM GMT
FRANKFURT, Aug 26 (Reuters) - A committee advising the U.S. Food and Drug Administration (FDA) will discuss Boehringer Ingelheim's Pradaxa pill on Sept. 20, raising the prospect of a speedy market entry for the first drug in a new class of blood thinners.

Cumberland Pharmaceuticals Announces Extension of FDA Review of Acetadote(R) Supplemental New Drug Application; New PDUFA Date in December 2010

Mon, 23 Aug 2010 12:00:00 AM GMT

Cumberland Pharmaceuticals Announces Extension of FDA Review of Acetadote Supplemental New Drug Application
PR Newswire
NASHVILLE, Tenn., Aug. 20
NASHVILLE, Tenn., Aug. 20 /PRNewswire-FirstCall/ ...

Arena Pharmaceuticals, Inc.'s Weight-loss Medication Lorcaserin Comparable to Orlistat or Sibutramine, Study

Fri, 06 Aug 2010 12:00:00 AM GMT
MedPage Today -- Combined with lifestyle modifications, the investigational weight-loss medication lorcaserin reduced weight without major safety problems, a multicenter, phase III trial showed.

Warner Chilcott, PLC Announces 3-Month Extension of PDUFA Date on Next Generation Actonel Product

Fri, 16 Jul 2010 12:00:00 AM GMT

ARDEE, Ireland, July 16 /PRNewswire-FirstCall/ -- Warner Chilcott plc (Nasdaq: WCRX) announced today that it has received a communication from the U.S. Food & Drug Administration (FDA) related to its next generation Actonel product (risedronate sodium) delayed-release tablets...

Protalix Biotherapeutics Receives PDUFA Date For Taliglucerase Alfa; May Not Rule Until 2011

Mon, 12 Jul 2010 12:00:00 AM GMT

CARMIEL, Israel, July 12 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that the Company's New Drug Application (NDA) for taliglucerase alfa has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA granted taliglucerase alfa a standard review...

Orexigen Therapeutics, Inc. Announces Assignment of January 31, 2011 PDUFA Date for Contrave(R) New Drug Application

Thu, 17 Jun 2010 12:00:00 AM GMT

Orexigen(R) Therapeutics Announces Assignment of January 31, 2011 PDUFA Date for Contrave(R) New Drug Application
PR Newswire
SAN DIEGO, June 17
SAN DIEGO, June 17 /PRNewswire-FirstCall/ -- Orexigen...

Questcor Pharmaceuticals, Inc. (Headquarters) Receives Notification of PDUFA Date Extension to September 11, 2010

Mon, 14 Jun 2010 12:00:00 AM GMT
UNION CITY, Calif., June 11 /PRNewswire-FirstCall/ -- Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR - News) today announced that it has received notification from the U.S. Food & Drug Administration (FDA) that the PDUFA date for Questcor's supplemental new drug application (sNDA) to approve Acthar for the treatment of infantile spasms (IS) has been extended to September 11, 2010. The FDA extended the...

AVANIR Pharmaceuticals Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010

Mon, 17 May 2010 12:00:00 AM GMT
ALISO VIEJO, Calif.--(BUSINESS WIRE)--AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Companys Complete Response to the October 2006 Approvable Letter for Zenvia (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA). The FDA considers this a Class 2 response and has assigned a Prescription...

FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq

Tue, 11 May 2010 12:00:00 AM GMT
JERSEY CITY, N.J.--(BUSINESS WIRE)--Lux Biosciences, Inc. today announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review its New Drug Application (NDA) for Luveniq (oral voclosporin) for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye on June 28, 2010.

Amylin Pharmaceuticals, Inc., Alkermes plc, Eli Lilly and Company BYDUREON (TM) FDA Review Timeline Set with PDUFA Action Date of October 22, 2010

Thu, 06 May 2010 12:00:00 AM GMT
SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., May 6, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA...

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM); to Issue New PDUFA Target Date

Fri, 23 Apr 2010 12:00:00 AM GMT
SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., April 22, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN - News), Eli Lilly and Company (NYSE:LLY - News) and Alkermes, Inc. (Nasdaq:ALKS - News) today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug...

FDA Panel to Review VIVUS, Inc. Anti-Obesity Drug QNEXA on July 15, 2010

Fri, 26 Mar 2010 12:00:00 AM GMT

"Review by the Advisory Committee represents a critical milestone for Qnexa and for VIVUS. We believe Qnexa, if approved, could become a treatment option for obese patients," stated Leland Wilson, chief executive officer of VIVUS. "We look forward to discussing the efficacy and safety data of Qnexa with the members of the Endocrinologic and Metabolic Drugs Advisory Committee...

Amylin Pharmaceuticals, Inc., Eli Lilly and Company Diabetes Drug Faces Crucial FDA Decision

Wed, 10 Mar 2010 12:00:00 AM GMT
Dow Jones -- After years of anticipation, a long-acting version of diabetes drug Byetta, sold by Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY), faces a crucial Food and Drug Administration approval decision this week.

ISTA Pharmaceuticals, Inc. Receives PDUFA Action Date of October 16, 2010 for FDA Review of Once-Daily XiDay(TM)

Tue, 09 Mar 2010 12:00:00 AM GMT
IRVINE, Calif., March 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA - News), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has granted XiDay a standard review time of ten months, assigning ISTA a Prescription Drug...

NicOx SA Announces FDA Advisory Committee to Discuss Naproxcinod on May 12; PDUFA Date Set for July 24, 2010

Mon, 08 Mar 2010 12:00:00 AM GMT
SOPHIA ANTIPOLIS, FRANCE--(Marketwire - 03/08/10) - NicOx S.A. (NYSE Euronext Paris: COX) 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 Management Advisory Committee to discuss the New Drug Application (NDA) for naproxcinod.
NicOx submitted an NDA for...

Arena Pharmaceuticals, Inc. Receives PDUFA Date for Lorcaserin NDA

Fri, 26 Feb 2010 12:00:00 AM GMT
SAN DIEGO, Feb. 26, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq:ARNA - News) 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 the lorcaserin New Drug Application (NDA). The acceptance of the lorcaserin NDA filing confirms that the application is sufficiently complete...

Amylin Pharmaceuticals, Inc.'s Exenatide Once Weekly New Drug Application Review Extended By FDA; New PDUFA Action Date March 12

Thu, 25 Feb 2010 12:00:00 AM GMT

FDA Panel to Review Salix Pharmaceuticals, Ltd. NDA for Xifaxan; Halts Trading in SLXP Stock

Tue, 23 Feb 2010 12:00:00 AM GMT

US FDA to Decide on Amgen Osteoporosis Drug, PDUFA Action Date Set to July 25, 2010

Mon, 22 Feb 2010 12:00:00 AM GMT

Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA

Wed, 17 Feb 2010 12:00:00 AM GMT