Zydus Lifesciences arm bags USFDA nod for ulcerative colitis drug Tofacitinib

Ahmedabad: Zydus Lifesciences Limited’s 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).

Medical Dialogues team had earlier reported that Zydus Cadila had received final approval from the USFDA to market Mesalamine Extended-Release Capsules in the strength of 0.375 g, (US RLD: Apriso). Mesalamine Extended-Release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.

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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.

Read also: USFDA grants Orphan Drug Designation to Zydus's ZYIL1 for treatment of Cryopyrin Associated Periodic Syndrome

Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.

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