Drug firm Zydus Cadila has received the US health regulator’s nod to market Mirtazapine orally disintegrating tablets, an anti-depressant, in the American market.
Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market the Mirtazapine orally disintegrating tablets USP in strengths 15mg, 30mg and 45mg, the company said in a BSE filing.
The company will manufacture the product at its facility in Baddi.
The Gujarat-based group has more than 115 approvals and has filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
Shares of Cadila Healthcare, the group’s listed entity, were trading at Rs 495.60 per scrip on BSE, up 0.21 per cent from its previous close.