Pharmaceutical company Zydus Lifesciences Ltd on Tuesday said it has received final and tentative approval from the United States Food and Drug Administration (US FDA) for Tofacitinib tablets, 5 mg, and 10 mg, respectively.

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Tofacitinib tablets are used to treat certain types of Arthritis.

The company claims to be the first Abbreviated New Drug Application (ANDA) applicant 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, according to a statement released by the company.

Tofacitinib tablets are used for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), it added.

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The company revealed that the drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad. Additionally, Tofacitinib tablets, 5 mg, and 10 mg had annual sales of $900 million in the United States.

With this approval, Zydus Group now has 352 approvals. The company, as of December 31, 2022, has filed over 440 ANDAs. Earlier today, Zydus Life was granted ‘Orphan Drug Designation’ by US FDA for ZYIL1 used to treat Cryopyrin Associated Periodic Syndrome (CAPS).

At the beginning of the month, the pharma company received final approval from USFDA for Erythromycin tablets USP, 250 mg and 500 mg, which is used to treat a wide variety of bacterial infections.

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The stocks of Zydus Life settled at Rs 478.35 apiece, up nearly 0.50 percent, when the market closed today, March 21, 2023. Additionally, the stock has been up nearly 14 percent this year.