Zydus receives final approval from the USFDA for Varenicline Tablets

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") 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 is 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.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 517.70 as compared to the previous close of Rs. 509.95. The total number of shares traded during the day was 31775 in over 1738 trades.

The stock hit an intraday high of Rs. 519.10 and intraday low of 508.80. The net turnover during the day was Rs. 16368493.00.

(*as of 31st March 2023)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA FinalApproval VareniclineTablets