Zydus Lifesciences on Tuesday said it has received final approval from the US health regulator to manufacture and market the generic version of Varenicline tablets indicated to treat smoking addiction.
The approval by the US Food and Drug Administration (USFDA) is for Varenicline tablets of strengths 0.5 mg and 1 mg, Zydus said in a regulatory filing.
The product will be launched shortly. It will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India, it added.
Varenicline tablets, 0.5 mg and 1 mg had annual sales of USD 501 million in the US, the company said citing IQVIA MAT March 2023 data.
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