Last Updated on June 20, 2023 by The Health Master
Ahmedabad: Zydus Lifesciences Limited (Zydus) has announced that it 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 company will launch the product shortly. The treatment of smoking addiction is indicated with Varenicline tablets.
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 (IQVIA MAT Mar 2023).
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.
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