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Sun Pharma Advanced Research Co Ltd Receives US FDA Response On Levetiracetam NDA


Saturday, 4 May 2013 08:59am EDT 

Sun Pharma Advanced Research Co Ltd announced the receipt of a complete response letter from U.S. Food and Drug Administration on New Drug Application for Levetiracetam Extended release tablets, 1000 mg and 1500 mg, an anti-epileptic product. In the complete response letter, the FDA specified that the clinical data submitted by SPARC establishes, bioequivalence in the fasted state. 

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