-8.15 (-0.89%) Natco Pharma has received the final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, 5mg, 10mg, 15mg, and 25mg strengths, from the U.S. Food and Drug Administration (USFDA), 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.
Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.