Natco Pharma Lenalidomide Capsules secures USFDA okay

Written by Ruchika Sharma Published On 2021-05-22T12:58:15+05:30 | Updated On 22 May 2021 12:58 PM IST

Natco Pharma Lenalidomide Capsules secures USFDA okay

Hyderabad: Pharma major, Natco Pharma Limited, announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, 5mg, 10mg, 15mg, and 25mg strengths, from the U.S. Food and Drug Administration (USFDA), and the tentative approval of the 2.5mg and 20mg strengths.

NATCO, along with its marketing partner Arrow International Limited (a U.S. affiliate of Teva Pharmaceutical Industries Ltd), previously settled the Paragraph IV litigation related to the product with Celgene (now part of Bristol-Myers Squibb), who sells the product under the brand-name REVLIMID.

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.

Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million.

The Company has seven manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751