Sun Pharma Advanced Research Company (SPARC) announced receipt of a Complete Response Letter from the US Food and Drug Administration (US FDA) on its New Drug Application (NDA) for levetiracetam extended-release tablets, 1000 mg and 1500 mg, an anti-epileptic product. A Complete Response Letter is a communication from the FDA to companies that an NDA cannot be approved in its present form.
In the Complete Response Letter, the US FDA specified that the clinical data submitted by SPARC establishes bioequivalence in the fasted state. However, the FDA has raised certain queries on the pharmacokinetic data in the fed state. SPARC is evaluating the contents of the letter and plans further discussions with the FDA.
EP News Bureau – Mumbai
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