Lupin gets USFDA nod for generic version of Arava Tablets

Leflunomide Tablets USP is a generic equivalent of Arava Tablets, 10 mg and 20 mg, of Sanofi- Aventis, Lupin said.

Mumbai: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Leflunomide Tablets USP, 10 mg and 20 mg, from the United States Food and Drug Administration(USFDA) to treat active rheumatoid arthritis (RA). 

Leflunomide Tablets USP, 10 mg and 20 mg, are indicated for the treatment of adults with active rheumatoid arthritis (RA).

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The product is a generic equivalent of Arava Tablets, 10 mg and 20 mg, of Sanofi- Aventis. The Product would be manufactured at Lupin's Pithampur (Unit 1) facility, India.

"Leflunomide Tablets USP (RLD: Arava Tablets) had an annual sales of approximately USD 44 million in the U.S. (IQVIA MAT December 2019), Lupin said in a BSE filing.

Headquartered in Mumbai, Lupin develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100marks in the U.S., India, South Africa and across Aia Pacific (LATAM), Europe and Middle-East regions.

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