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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for the approval to market Rasagiline mesylate 0.5 and 1.0mg tablets.
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Watson’s Rasagiline mesylate tablets are generic versions of Teva Neuroscience’s Azilect tablets, which are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease as initial monotherapy and as adjunct therapy to levodopa.
Previously, a lawsuit has been filed against Watson on 1 October 2010 by Teva Neuroscience, Teva Pharmaceuticals US and Teva Pharmaceutical Industries 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 resulted 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.