USFDA approves Zydus Varenicline Tablets for smoking addiction treatment
Ahmedabad: Zydus Lifesciences Limited has announced that the company 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 are indicated to treat smoking addiction.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Commenting 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.”
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