Corporate News     13-Jun-23
Zydus Lifesciences receives USFDA approval for Varenicline Tablets
Zydus Lifesciences 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 (USRLD: Chantix® Tablets). The product will be launched shortly.

Varenicline tablets is 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 (IQVIA MAT Mar. 2023).

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.

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