Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Varenicline Tablets, 0.5 mg and 1 mg, the company announced through an exchange filing. The product will be launched shortly.
Varenicline tablets are indicated to treat smoking addiction. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Varenicline Tablets, 0.5 mg and 1 mg had annual sales of USD 501 mn in the United States.
The group now has 374 approvals and has so far filed over 442 ANDAs since the commencement of the filing process in FY 2003-04.
