News & Analysis » India
Glenmark Pharma Arm Gets US FDA Tentative Approval For Riluzole
July 29, 2010, Thursday, 05:11 GMT | 00:11 EST | 09:41 IST | 12:11 SGT
(RTTNews) - Glenmark Pharmaceuticals Ltd. said its US subsidiary Glenmark Generics Inc. obtained the US FDA tentative approval for Riluzole 50 mg tablets, the generic version of Rilutek tablets manufactured by Sanofi Aventis US LLC.
Rilutek is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
As per IMS Health data, the Rilutek sales were $47 million for the 12-month period ending March 2010.
Based on the tentative approval, Glenmark Generics should be able to launch the Riluzole tablets upon patent expiry in June 2013, the company added.
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