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Zydus Cadila gets final USFDA nod to market generic rheumatoid arthritis tablets

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Press Trust of India New Delhi

Drug firm Zydus Cadila Thursday said it has received final nod from the US health regulator to market generic Leflunomide tablets, used for treatment of rheumatoid arthritis.

The company has received final approval from the United States Food and Drug Administration (USFDA) to market Leflunomide tablets in the strengths of 10 mg and 20 mg, Zydus Cadila said in a statement.

The tablets will be manufactured at the group's formulations manufacturing facility at Baddi in Himachal Pradesh, it added.

The tablets are generic version of Arava tablets, Zydus Cadila said.

The drug is used to treat rheumatoid arthritis, a condition affecting multiple small and large joints of the body, it added.

 

The group now has 263 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it said.

Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 325.90 per scrip on the BSE, down 1.17 per cent from its previous close.

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First Published: Apr 25 2019 | 3:20 PM IST

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