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With the United States Food and Drug Administration (USFDA) disapproving Sun Pharma Advanced Research Company’s (Sparc) new drug application for an anti depressant drug in its present form, Sparc is evaluating the commercial viability of the product.
Sparc is the research arm of Sun Pharma, engaged in research and development of medicines.
The US regulator has sought more data and additional studies related to the efficacy and safety of the Indian company’s Venlafaxine extended release tablets.
However, earlier last week, the company said it had received the US health regulator’s nod to market a generic version of another anti depressant drug, that of Eli Lilly and Company's Cymbalta, in the American market.
The company had received the nod from the USFDA to market Duloxetine capsules. Since the Indian company was the first to file the abbreviated new drug application for the generic Cymbalta, it was eligible to share the 180 day marketing exclusivity in the US.
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