Zydus Cadila gets USFDA nod for anti-depressant drug
Estimated sales of drug were $256 mn in 2013; Ahmedabad-based group has now 87 approvals from the USFDA
Press Trust of India 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.