Zydus Cadila gets USFDA nod for anti-depressant drug

NEW DELHI: Drug major Zydus Cadila has received approval from the US health regulator to market Bupropion Hydrochloride extended-release tablets, an anti-depressant medicine, in the American market.

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Bupropion Hydrochloride Extended-release Tablets USP (XL) in the strength of 300 mg, the company said in a statement.

The drug falls in the anti-depressants segment, it added. As per IMS sales data, the estimated sales of Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg was $255.9 million in 2013.

The Ahmedabad-based group has now 87 approvals from the USFDA and so far it has filed 216 abbreviated new drug applications (ANDAs) since the commencement of filing process in FY 2003-04.