Live
- Hailstorm-hit Vistara flight returns to Bhubaneswar airport
- PM Modi-led govt saved people during pandemic: Union Minister Anurag Thakur
- Heat wave grips Telangana, mercury crosses 46 degrees Celsius in few places
- New India believes in giving a dose, not dossiers, to terror masterminds: PM Modi
- Nagarkurnool MLA Kuchukulla Rajesh Reddy should send Malluravi to Parliament for the third time
- Awareness conference on Mayday under the auspices of Legal Service Authority
- Adani Power logs 37 per cent revenue growth in FY24, consolidated PBT more than doubled
- Rohit said 'just show us what you can do', recalls Shivam Dube post T20 WC selection
- Resignations of Lovely, Naseeb and Basoya indicate Congress high command's disconnect with ground reality
- Hamas standing in way of ceasefire, Blinken says during meeting with Israeli PM Netanyahu
Dr Reddy's gets USFDA nod for lenalidomide capsules
Dr Reddy’s net zooms 30% to Rs 992 cr in Q2
Dr Reddy’s Laboratories Ltd received the final approval from the US Food and Drug Administration (USFDA) 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 capsules.
Hyderabad: Dr Reddy's Laboratories Ltd received the final approval from the US Food and Drug Administration (USFDA) 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 capsules.
With this approval, Dr Reddy's is eligible for 180 days of generic drug exclusivity for lenalidomide capsules, 2.5 mg and 20 mg. In September 2020, the company 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 the patents.
In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the US beginning on a confidential date after March 2022 subject to regulatory approval. The agreed-upon percentages remain confidential.
As part of the settlement, Dr Reddy's is also licensed to sell generic lenalidomide capsules in the US without volume limitation from January 31, 2026. Marc Kikuchi, CEO, North America Generics, Dr Reddy's Laboratories, said: "We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients."
