Drug firm Zydus Cadila Healthcare Ltd. has received the U.S. health regulator's nod to market Mirtazapine orally disintegrating tablets, an antidepressant, in the American market.
The drug maker received the final approval from the U.S. Food and Drug Administration (U.S. FDA) to market 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 Ltd., the group's listed entity, rose as much as 1.17 percent to Rs 500.