New Delhi: Zydus Pharmaceuticals (USA) Inc has received final approval from the US health regulator to market Clomipramine Hydrochloride capsules, used to treat obsessive compulsive disorder (OCD).
The company has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 25 mg, 50 mg, and 75 mg, Zydus Cadila said in a BSE filing.
The company will produce the drug at the group’s formulations manufacturing facility at SEZ, Ahmedabad.
Clomipramine hydrochloride capsule is used to treat obsessive compulsive disorder, which is characterised by uncontrollable, re-occurring thoughts and behaviours.
The company has more than 180 approvals and so far filed over 310 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
Zydus Pharmaceuticals Inc is a wholly-owned subsidiary of Cadila Healthcare Ltd.