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Dr. Reddy’s gets approval for Lenalidomide Capsules from US FDA

Dr. Reddy’s today announced that it has received approval for Lenalidomide capsules from the US Food and Drug Administration (USFDA).

“Dr. Reddy’s today announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of REVLIMID® (lenalidomide) Capsules, from the U.S. Food and Drug Administration (USFDA),” the company said in a regulatory filing.

With this approval, the company is eligible for 180 days of generic drug exclusivity for Lenalidomide Capsules.

“We are pleased with the Agency’s approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity,” says Marc Kikuchi, CEO, North America Generics, Dr Reddy’s Laboratories.

“We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients.”

In September 2020, Dr. Reddy’s announced a settlement agreement of their litigation with Celgene, the maker of REVLIMID® (lenalidomide) Capsules and a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for the branded drug.

 

 

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