NATCO receives Tentative Approval for Olaparib Tablets from the United States Food and Drug Administration (U.S. FDA)

Hyderabad: NATCO Pharma Limited received tentative approval from the U.S. FDA for Olaparib, 100 mg, and 150 mg, as bioequivalent to reference listed drug (RLD) Lynparza® tablets of AstraZeneca Pharmaceuticals for the indication in the approved labelling. NATCO will be manufacturing Olaparib tablets and our partner Alembic Pharmaceuticals Limited (Alembic), would be distributing the product in the U.S. The Para IV litigation is on-going. Olaparib tablets had estimated sales of approximately USD 1.4 billion in the U.S. for 12 months ending Mar’26 as per industry sales data.

The release as fetched from its publisher. natcopharma.co.in ↗