Natco Pharma Gets US FDA Tentative Approval for Olaparib Tablets

Natco Pharma Limited has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its Olaparib tablets (100 mg and 150 mg). These are bioequivalent to AstraZeneca's Lynparza® tablets. Natco will manufacture the product, with its partner Alembic Pharmaceuticals Limited handling distribution in the U.S. The U.S. market for Olaparib tablets was approximately USD 1.4 billion for the 12 months ending March 2026. Para IV litigation is ongoing.