Shares of Zydus Lifesciences were trading in the early hours of March 22, after the company’s subsidiary received USFDA approval for tofacitinib tablets.

Zydus Pharmaceuticals (USA) Inc, a subsidiary of Zydus Lifesciences, has received final approval from the US Food and Drug Administration (USFDA) for tofacitinib tablets 5 mg and tofacitinib tablets 10 mg, according to an exchange filing.

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

Tofacitinib is indicated for treating adult patients with moderately to severely active rheumatoid arthritis and adult patients with active psoriatic arthritis. The company said it is also indicated for treating adult patients with moderately to severely active ulcerative colitis (UC).

The drug will be produced at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

It added that the 5 mg and 10 mg tofacitinib tablets had annual sales of $900 million in the US.

The company announced on March 21 that USFDA had granted ZYIL1 Orphan Drug Designation (ODD) for treating patients with cryopyrin-associated periodic syndrome (CAPS).

At 9:21 am, Zydus Lifesciences was quoted at Rs 480.35 on the BSE, up Rs 2.40, or 0.5%.