Zydus receives USFDA approval for Tofacitinib Tablets

Zydus Lifesciences' 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).

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