Drug Approval | September 17, 2025
FDA approves Lupin’s Lenalidomide capsules
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone
The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product
Lenalidomide is used to treat various types of cancers.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
For the full financial year FY25, revenue from operations grew 9 per cent to Rs. 11,537.8 crore, compared to Rs. 10,588 crore in FY24.
Lenalidomide capsules are a prescription medicine used in adults for the treatment of multiple myeloma.
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