Shares of Zydus Lifesciences traded in the green in the early hours on March 22 after the company's subsidiary received the USFDA approval for Tofacitinib Tablets.
Zydus Lifesciences subsidiary Zydus Pharmaceuticals (USA) Inc has received the final approval for Tofacitinib Tablets, 5 mg and tentative approval for Tofacitinib Tablets, 10 mg from the United States Food and Drug Administration (USFDA), according to an exchange filing.
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 moderate-to-severe active ulcerative colitis (UC), the company said.
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 $900 million in the US, it added.
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The company on March 21 announced that the US drug regulator has granted the ‘Orphan Drug Designation’ (ODD) to ZYIL1, for the treatment of patients with Cryopyrin Associated Periodic Syndrome (CAPS).
At 9:21am, Zydus Lifesciences was quoting at Rs 480.35, up Rs 2.40, or 0.50 percent, on the BSE.
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