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.”

Varenicline Tablets, 0.5 mg and 1 mg had annual sales of USD 501 mn in the United States (IQVIA MAT Mar. 2023). The group now has 374 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

Recently, Medical Dialogues has reported that the company has also received final approval from the USFDA to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg (USRLD: Arthrotec Delayed-Release Tablets).

Read also: Zydus Lifesciences wins USFDA nod for Diclofenac Sodium and Misoprostol Delayed Release Tablets