Overview
- Lupin received U.S. FDA approval to market Lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg strengths.
- The capsules are bioequivalent to Bristol‑Myers Squibb’s Revlimid and are indicated for multiple myeloma, post‑auto‑HSCT maintenance and certain 5q‑MDS anaemias.
- The approved product is slated to be manufactured at Lupin’s Pithampur facility in India.
- IQVIA data cited in filings peg U.S. annual Lenalidomide sales at about $7.5 billion.
- The U.S. FDA issued six observations for Lupin’s Nagpur injectable plant, the company said it will respond within the stipulated timeframe and the stock traded lower intraday.