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Biotech / Medical : Momenta Pharmaceuticals Inc.

MNTA 52.48

0.0%

Oct 2 5:00 PM EST

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To: rkrw who wrote (2665)	12/10/2010 3:46:22 PM
From: tuck	Read Replies (1) of 3027

The THIRD attempt at a Citizen's Petition from Teva on Copaxone: >>JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA - News) today announced that the company has filed a Citizen Petition (CP) with the U.S. Food and Drug Administration (FDA) requesting that the FDA refuse to approve any abbreviated new drug application (ANDA) for a purported generic version of COPAXONE® (glatiramer acetate injection). Teva’s requests in this CP are based on the inability to establish acceptable “sameness” of the active ingredients in glatiramer acetate, the complexity of the mechanism of action of a glatiramoid and the inapplicability of leveraging conventional pharmacokinetic and pharmacodynamic testing methods to demonstrate bioequivalence. Teva urges that any purported follow-on version of COPAXONE® undergo pre-clinical testing as well as full-scale clinical trials with measured clinical endpoints in multiple sclerosis (MS) patients to prove safety and efficacy. Teva also requests that the FDA convene a multidisciplinary Advisory Committee to consider the approval of follow-on glatiramer acetate products in the interest of public health.<< snip Cheers, Tuck

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