Ahmedabad-headquartered pharmaceutical company Zydus Lifesciences announced on Tuesday that it has received approval for manufacturing and marketing a generic version of Varenicline tablets from the US health regulator United States Food and Drug Administration (USFDA). 

In a regulatory filing, Zydus said that the USFDA approved the manufacturing of Varenicline tablets, which are used to treat smoking addiction, of strengths 0.5 mg and 1 mg. According to IQVIA MAT data for March 2023, the annual sales of Varenicline Tablets of the same strength in the US market stood at $501 million. 

The generic tablets would be manufactured at the group’s Ahmedabad SEZ formulation manufacturing facility. The company added that the product will be launched shortly.

As of 31st December 2022, Zydus Group has filed over 442 Abbreviated New Drug Applications (ANDAs) since the filing process began in FY04 and received a total of 374 approvals. It got the final approval to manufacture and market 50 mg/mL single-dose vials of ephedrine sulphate injectable USP in May.

Shares of the mid-cap pharma company closed at Rs 518 on Tuesday, up by 1.57% from the previous closing price, extending its upward movement for the second consecutive session.