Sun Pharma Advanced Research Company (SPARC) has received a complete response letter from the US Food and Drug Administration (USFDA) on its New Drug Application (NDA) for Levetiracetam Extended-release tablets, 1000mg and 1500mg, an anti-epileptic product. A complete response letter is a communication from the USFDA to companies that an NDA cannot be approved in its present form.
In the complete response letter, the USFDA specified that the clinical data submitted by SPARC establishes bioequivalence in the fasted state. However, the USFDA has raised certain queries on the Pharmacokinetic data in the fed state. The company is evaluating the contents of the letter and is planning for further discussions with the USFDA.
SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.
