Natco Pharma, one of the few Indian companies to venture into new drug discovery research, announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, 5mg, 1 Omg, 15mg, and 25mg strengths, from the U.S. Food and Drug Administration (FDA), and the tentative approval of the 2.5mg and 20mg strengths.
NATCO, along with its marketing partner Arrow International (a U.S. affiliate of Teva Pharmaceutical Industries), previously settled the Paragraph IV litigation related to the product with Celgene (now part of Bristol-Myers Squibb), who sells the product under the brand-name REVLIMID. NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
Shares of the company gained Rs 57.90, or 6.21%, to settle at Rs 990.80. The total volume of shares traded was 140,670 at the BSE (Friday).