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 Venlafaxine Extended-release tablets in 300 mg strength, an anti-depressant 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 FDA has requested for some additional studies related to efficacy and safety. Based on the FDA’s feedback, the company is evaluating the commercial viability of this product.
SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.
