Dr. Reddy’s gets USFDA nod for generic anti-cancer drug
The Hindu
Dr. Reddy’s Laboratories has received U.S. Food and Drug Administration (USFDA) approval for a generic version of anti-cancer drug Revlimid (lenalidomide) capsules.The health regulator gave final appr
Dr. Reddy’s Laboratories has received U.S. Food and Drug Administration (USFDA) approval for a generic version of anti-cancer drug Revlimid (lenalidomide) capsules.
The health regulator gave final approval for the company’s ANDA (abbreviated new drug application for Lenalidomide capsules), 2.5 mg and 20 mg strengths and tentative approval for 5 mg, 10 mg, 15 mg and 25 mg strengths. With the approval, the company will be eligible for 180 days of generic drug exclusivity for Lenalidomide capsules 2.5 mg and 20 mg, Dr. Reddy’s said in a release on Tuesday.
“We are pleased with the approval of Lenalidomide capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity... look forward to bringing a more affordable generic version of this drug to market,” said Marc Kikuchi, CEO-North America Generics.
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