Zydus Lifesciences gets FDA final approval for Varenicline Tablets

Zydus Lifesciences has been granted final approval from the US Food and Drug Administration (FDA) to manufacture and market Varenicline Tablets, 0.5 mg and 1 mg, a smoking cessation aid. The product is set for a near-future launch.

Varenicline Tablets, a generic of Chantix Tablets, are indicated for treating nicotine addiction. The drug will be produced at Zydus Lifesciences’ formulation manufacturing facility located at the Ahmedabad SEZ in India.

The tablets, which reported annual sales of $501 million in the United States (IQVIA MAT Mar. 2023), represent a significant market opportunity for Zydus Lifesciences.

Zydus Lifesciences secures FDA final approval for Varenicline Tablets. Photo courtesy of Zydus Cadila.

With this approval, the group’s tally has reached 374 approvals, and the company has filed over 442 Abbreviated New Drug Applications (ANDAs) since it initiated the filing process in the fiscal year 2003-04.

Dr Sharvil Patel — Zydus Lifeciences Managing Director 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.”