Zydus Receives USFDA's Final Approval for Varenicline Tablets

Zydus Lifesciences Limited (Zydus) has announced that the United States Food and Drug Administration (USFDA) has granted final approval to manufacture and market Varenicline Tablets, 0.5 mg and 1 mg. The product will be released soon by the firm. Varenicline tablets are prescribed to treat smoking addiction. The medication will be manufactured at the Zydus group's formulation manufacturing facility in Ahmedabad SEZ, India.

Speaking on the approval, Dr Sharvil Patel, Managing Director, Zydus Lifeciences Limited, said, "We are pleased with the approval and imminent launch of generic Verinicline, which validates the agility of our supply chain as well as the focused efforts by our R&D team, which will improve access and availability of the generic product for patients in the US market. This an important product which will support our growth plans in US market in the current fiscal." In the United States, Varenicline tablets, 0.5 mg and 1 mg, had annual sales of $ 501 million. Zydus informed that the group now has 374 approvals and has so far filed over 442 ANDAs as of March 2023, since the commencement of the filing process in FY 2003–04.