Mylan Wins Final FDA Approval for ANDA; Aeterna Zentaris Wins FDA Special Protocol Assessment for Phase 3 Registration Trial Print E-mail
By Staff and Wire Reports   
Friday, 28 December 2012 20:16
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 28, 2012.

Mylan Inc. (Nasdaq: MYL) announced its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets USP, 50 mg.

This product is the generic version of Pfizer's Dilantin® Chewable Tablets, which are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments.


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Aeterna Zentaris Inc. (NASDAQ: AEZS)
announced that it has reached an agreement with the U.S. FDA on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.

This will be an open-label, randomized, multicenter Phase 3 trial conducted in North America and Europe, comparing AEZS-108 with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. The trial will involve approximately 500 patients and the primary efficacy endpoint is improvement in median Overall Survival.

The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a Biologics License Application ("BLA") or New Drug Application ("NDA"). Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial.



Also Friday:



Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that Ron Cohen, M.D., President & CEO, will present at the upcoming 31st Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2013 at 11:00 a.m. Pacific Time at the Westin St. Francis Hotel in San Francisco, CA.

Bristol-Myers Squibb Company (NYSE: BMY)
and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved ELIQUIS® (apixaban).

HPIL Holding (OTCQB: HPIL)
is pleased to announce that its wholly owned subsidiary HPIL ENERGYTECH INC., on December 20, 2012, entered into a Cooperation Agreement (the "Agreement") with TrueSkill Energen Pvt. Ltd., a private limited company focused on marketing renewable energy products and solutions.

Mylan Inc. (Nasdaq: MYL)
today announced that its partner Famy Care Ltd. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg.

Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a development stage biopharmaceutical company, announced today that it has recently received approximately $521,000, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax Certificate Transfer Program (the Program).  

Verisante Technology, Inc. (TSX VENTURE:VRS)(OTCQX:VRSEF)
(the "Company" or "Verisante"), a leader in cancer detection technology, announced that, subject to the approval of the TSX Venture Exchange, a total of 675,000 stock options were issued to Directors and Officers of the Company on the recommendation of the Compensation Committee of Directors.

Watson Pharmaceuticals, Inc. (NYSE: WPI)
today confirmed that Actavis, Inc., which was acquired by Watson in October, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market bortezomib.



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