Zydus receives final FDA approval for new strengths of generic Xeljanz

21 March 2023

Zydus Lifesciences (NYSE: ZYDUSLIFE) today revealed it has received final approval for Tofacitinib Tablets, 5mg and tentative approval for Tofacitinib Tablets, 10mg, generic versions of US pharma giant Pfizer’s (NYSE: PFE) Xeljanz from the US Food and Drug Administration (FDA).

Zydus was one of the first abbreviated new drug applications (ANDA) to submit a substantially complete ANDA with a paragraph IV certification for Tofacitinib Tablets, 5mg and therefore is eligible for 180 days of shared generic drug exclusivity for the generic. Zydus gained180-exclusivity for tofacitinib extended-release tablets, 11mg and 22mg in the USA in 2021.

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).

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