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  • Sun Pharma bags USFDA...

Sun Pharma bags USFDA okay for generic lenalidomide capsules

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-02-11T12:30:40+05:30  |  Updated On 11 Feb 2023 11:58 AM GMT
Sun Pharma bags USFDA okay for generic lenalidomide capsules
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Mumbai: Pharma major, Sun Pharmaceutical Industries Limited, has announced that one of its wholly owned subsidiaries has received final approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for generic lenalidomide Capsules, 5mg, 10mg, 15mg, 25mg and tentative approval for 2.5mg, 20mg.The respective product approval is based on Revlimid...

Mumbai: Pharma major, Sun Pharmaceutical Industries Limited, has announced that one of its wholly owned subsidiaries has received final approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for generic lenalidomide Capsules, 5mg, 10mg, 15mg, 25mg and tentative approval for 2.5mg, 20mg.

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product.

Read also: Sun Pharma Gets CDSCO panel nod for active post marketing surveillance of Tofacitinib ER Tablets

In June 2021, Sun Pharma had entered into a settlement with Celgene Corporation to resolve the patent litigation regarding Sun Pharma’s generic lenalidomide capsules. Pursuant to the terms of this settlement, Celgene granted Sun Pharma a license to Celgene’s patents required to manufacture and sell certain limited quantity of generic lenalidomide capsules in the US beginning sometime after March 2022. In addition, the license allows Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

Read also: Sun Pharma settles patent dispute with Celgene over generic Revlimid

Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.

Read also: Sun Pharma Q3 results: Consolidated net profit rises 5 percent YoY

sun pharmasun pharma newsUSFDAlenalidomide CapsulesRevlimid CapsulesCelgene
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor 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

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