New Drug Application News and Research

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Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA). The FDA will consider the committee's advice as part of its final assessment of the NDA.

19 Jun 2010

Matrix Laboratories receives FDA approval for generic version Zocor Tablets: Mylan

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg, the generic version of Merck & Co.'s Zocor Tablets, a treatment for high cholesterol. The product will be distributed by Mylan Pharmaceuticals Inc.

18 Jun 2010

Inspire's TIGER-1 Phase 3 clinical trial data with denufosol for CF presented at 33rd ECFS

Inspire Pharmaceuticals, Inc. announced today that data is being presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during an oral presentation and poster presentations at the 33rd Annual European Cystic Fibrosis Society (ECFS) Conference June 16 - 19, 2010 in Valencia, Spain.

18 Jun 2010

BioSante announces presentation of LibiGel safety update at ENDO 2010

BioSante Pharmaceuticals, Inc., will present a LibiGel safety update at the 2010 Annual Meeting of the Endocrine Society (ENDO), being held from June 19-22, 2010 in San Diego, California.

18 Jun 2010

USFDA approves Sun Pharma's generic Xanax ANDA

Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Xanax®, alprazolam tablets.

18 Jun 2010

HRA Pharma announces FDA Advisory Committee approval for ulipristal acetate as emergency contraceptive

HRA Pharma announced today that the U.S. Food and Drug Administration's (FDA) Advisory Committee for Reproductive Health Drugs voted 11 to 0 that the company's application provided sufficient information to conclude that ulipristal acetate is effective and safe for use as an emergency contraceptive.

18 Jun 2010

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

18 Jun 2010

$FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer$

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

18 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

ACT awarded patent for production processes of RPE cells from hESCs

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that it has been issued U.S. Patent Number 7736896, which is broadly directed to processes developed by ACT scientists for the production of retinal pigment epithelial (RPE) cells from human embryonic stem cells (hESCs).

17 Jun 2010

USFDA approves Sun Pharma's generic Keppra Injection ANDA

Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Keppra® Injection, levetiracetam injection.

17 Jun 2010

New drug application for ulipristal acetate as emergency contraceptive misleading, says Family Research Council

Tomorrow, the Food and Drug Administration (FDA) will hold a hearing to consider approval of a new drug application for an abortifacient drug, ulipristal acetate, as an emergency contraceptive, or a new "Plan B."

17 Jun 2010

Trius Therapeutics reaches agreement with FDA under SPA for Phase 3 study of torezolid phosphate for ABSSSI

Trius Therapeutics, Inc. announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study for the oral dosage form of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI).

16 Jun 2010

Phase 3 U.S. registration study of LODOTRA shows improvement in patients with RA

Horizon Pharma, Inc., announced today that data from the Phase 3 U.S. registration study of LODOTRA, a circadian cytokine modulator and novel modified-release, low-dose prednisone tablet, showed a statistically significant improvement in American College of Rheumatology response criteria in patients with rheumatoid arthritis.

16 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Biodel Inc. announced today that the following oral and poster presentations describing results from studies of the company's product candidates will be presented during the 70th Scientific Sessions of the American Diabetes Association this month in Orlando, Florida:

14 Jun 2010

Intellipharmaceutics International files Protonix ANDA with FDA

Intellipharmaceutics International Inc. today announced that is has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic of Protonix® (delayed release pantoprazole sodium). Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.

14 Jun 2010

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Cell Therapeutics, Inc. today announced that the Italian Medicines Agency ("AIFA"), the national authority responsible for drug regulation in Italy, has approved the facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of CTI's drug candidate pixantrone.

14 Jun 2010

Delcath Systems to host conference call to update shareholders about recent progress

Delcath Systems, Inc. a development stage, specialty pharmaceutical and medical device company focused on oncology will host a conference call to discuss recent corporate developments on Tuesday, June 15, 2010 at 4:30 p.m., Eastern. Eamonn P. Hobbs, the Company's President and CEO, David McDonald, CFO, and Krishna Kandarpa, MD, Chief Medical Officer, will be on hand during the call and webcast.

11 Jun 2010

Innovaro facilitates protein transduction technology licensing between Trojan Technologies, Trojantec

Innovaro, a comprehensive innovation solutions company, is pleased to announce that it has facilitated the completion of a licensing transaction between Trojan Technologies USA, a company recently formed by Verdant Ventures Advisors II, LLC, and Trojantec Ltd, a London and Cyprus based biopharmaceutical company.

11 Jun 2010

New Drug Application News and Research

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

Matrix Laboratories receives FDA approval for generic version Zocor Tablets: Mylan

Inspire's TIGER-1 Phase 3 clinical trial data with denufosol for CF presented at 33rd ECFS

BioSante announces presentation of LibiGel safety update at ENDO 2010

USFDA approves Sun Pharma's generic Xanax ANDA

HRA Pharma announces FDA Advisory Committee approval for ulipristal acetate as emergency contraceptive

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

FDA approves Jevtana in combination with prednisone for metastatic hormone-refractory prostate cancer

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

ACT awarded patent for production processes of RPE cells from hESCs

USFDA approves Sun Pharma's generic Keppra Injection ANDA

New drug application for ulipristal acetate as emergency contraceptive misleading, says Family Research Council

Trius Therapeutics reaches agreement with FDA under SPA for Phase 3 study of torezolid phosphate for ABSSSI

Phase 3 U.S. registration study of LODOTRA shows improvement in patients with RA

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Intellipharmaceutics International files Protonix ANDA with FDA

CTI announces AIFA approval for manufacture of pixantrone at NerPharMa facility

Delcath Systems to host conference call to update shareholders about recent progress

Innovaro facilitates protein transduction technology licensing between Trojan Technologies, Trojantec

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