Zydus Cadila gets USFDA nod to market antidepressant drug

NEW DELHI, 08 OCTOBER 2017:

Drug firm Zydus Cadila has received final approval from the US health regulator to market Amitriptyline hydrochloride tablets used for treatment of depression in the American market.

The company has received final approval from the United States Food and Drug Administration (USFDA) to market the tablets in strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg, Cadila Healthcare, the listed entity of the group said in a BSE filing on Saturday.

The drug, used in treating depression, will be manufactured at the group's formulations facility at SEZ Ahmedabad, it added.

"The group now has more than 160 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process by the company," it added.