Dr Reddy's gains FDA nod for generic Revlimid

Indian generic drugs major Dr Reddy’s Laboratories (BSE: 500124) has received final approval from the US Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for lenalidomide Capsules, in 2.5mg and 20mg strengths, and tentative approval for 5mg, 10mg, 15mg, and 25mg strengths.

This is a therapeutic equivalent generic version of Revlimid, developed by US biotech Celgene, which is now wholly-owned by Bristol Myers Squibb (NYSE: BMY). The branded drug has annual sales of around $8 billion

With this approval, Dr Reddy’s is eligible for 180 days of generic drug exclusivity for cancer treatment lenalidomide Capsules, 2.5mg and 20mg.