Look for Drugs and Conditions

Representative image

Zydus gets final USFDA approval to market Tofacitinib tablets

Zydus Lifesciences has received final and tentative United States Food and Drug Administration (USFDA) approval to market Tofacitinib Tablets, 5 mg and tentative approval to market Tofacitinib Tablets, 10 mg.

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.

Zydus said that 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.

The company added that 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).


0 Comments
Be first to post your comments

Post your comment

Related Articles

Ad 5