Drugmaker Cipla has received regulatory approval in the US for Lenalidomide, its generic therapeutic equivalent of cancer drug Revlimid from Bristol Myers Squibb (BMS).
Cipla said it had received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide capsule in multiple strengths of 5 mg, 10 mg, 15 mg and 25 mg from the United States Food and Drug Administration (USFDA). The product would be shipped out soon, it added.
What is Lenalidomide?
Lenalidomide is a prescription drug indicated for several blood-related malignancies in adults, including Multiple Myeloma, a type of bone marrow cancer.
Depending on the type of cancer, it is used as a monotherapy or in combination as a part of a first-line regimen, maintenance regimen, or relapsed settings, a note from Cipla said. Lenalidomide capsules are not given to pregnant women, and their safety and efficacy in children are not known, it added.
The BMS (Celgene) drug’s global quarterly sales grossed $2.5 billion, with the US accounting for a lion's share of it. But it is facing competition from a host of generic companies. Hyderabad-based Natco was the first to get approval in March for the sale of its generic version in the US.