Sun Pharma units product in present form disapproved by FDA
According to the announcement made by Sun Pharma Advanced Research Company (SPARC), their New Drug Application (NDA), for a product of the anti-depressant variety in the present form has been disapproved by USFDA.It also stated that the USFDA has issued a letter that demands additional studies that detail about the safety and efficacy of the product. The product in discussion is Venlafaxine 300 mg tablets with extended release. The company, SPARC has received a complete response letter, which is a communication that the USFDA provides when a new drug application cannot be approved in the present form.
The company aims at working in this direction and according to the USFDAs remarks and feedback, the company would be evaluating whether the product can be commercial viable. The necessary actions would be taken and the company aims at providing the communication demanded by the FDA.