Zydus receives final and tentative Approval from the USFDA for Tofacitinib Tablets, 5 mg and 10 mg

Zydus Lifesciences Limited's (including its subsidiaries/affiliates, hereinafter referred to as "Zydus") subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval for Tofacitinib Tablets, 5 mg and tentative approval for Tofacitinib Tablets, 10 mg (USRLD: Xeljanz® Tablets) from the United States Food and Drug Administration (USFDA).

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Tofacitinib Tablets, 5 mg and therefore is eligible for 180 days of shared generic drug exclusivity for Tofacitinib Tablets, 5 mg.

Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis and for the treatment of adult patients with active psoriatic arthritis. It is also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad (India).

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of USD 900 mn in the United States (IQVIA MAT Dec. 2022).

The group now has 352 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 477.95 as compared to the previous close of Rs. 475.85. The total number of shares traded during the day was 17087 in over 1180 trades.

The stock hit an intraday high of Rs. 480.00 and intraday low of 473.95. The net turnover during the day was Rs. 8155906.00.

(*as of 31st December 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 FinalApproval Tofacitinib ZydusPharmaceuticalsUSA USFDA