Drug Approval | March 09, 2023
Eugia Pharma receives USFDA approval for Lenalidomide Capsules
The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone
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
Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency
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.
Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings
Lenalidomide Sandoz is indicated for use in several critical haematology-oncology conditions, per latest ESMO guidelines
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
Nat-Lenalidomide, a generic alternative to Revlimid, expands affordable treatment options for patients with multiple myeloma and patients with transfusion-dependent anaemia due to myelodysplastic syndromes (MDS)
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