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Watson files for approval of Parkinson's disease generic drug in USA.

M2 PHARMA-October 5, 2010-Watson files for approval of Parkinson's disease generic drug in USA(C)2010 M2 COMMUNICATIONS

5 October 2010 - US generic drugs maker Watson Pharmaceuticals Inc (NYSE: WPI) said today that its subsidiary Watson Laboratories Inc has filed for approval to market rasagiline mesylate 0.5 and 1.0 mg tablets with the US Food and Drug Administration (FDA) for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

The rasagiline mesylate tablets are generic versions of Teva Neuroscience Inc Azilect Tablets which are indicated as initial monotherapy and as adjunct therapy to levodopa.

As a result Teva Neuroscience, Teva Pharmaceuticals USA Inc and Teva Pharmaceutical Industries Ltd (TLV: TEVA) filed suit against Watson on 1 October 2010 in the US District Court for the District of New Jersey seeking to prevent Watson from commercialising its product prior to the expiration of US Patent No. 5,453,446. Teva's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until 16 November 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Watson believes it may be a first applicant to submit application for the 0.5 and 1.0 mg generic versions of Azilect and, if the applications is approved, may be entitled to 180 days of shared generic market exclusivity with other applicants that filed on the same day as Watson.

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Publication:M2 Pharma
Date:Oct 5, 2010
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