Sun Pharma Advanced Research Company (SPARC) announced the receipt of a complete response letter from the US Food and Drug Administration (FDA) on its New Drug Application (NDA) for Venlafaxine extended-release tablets, 300 mg, 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, SPARC is evaluating the commercial viability of this product.
EP News Bureau– Mumbai
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