Alembic Pharma Partner Natco Pharma Gets USFDA Tentative Approval for Olaparib Tablets

Alembic Pharmaceuticals Limited announced that its partner, NATCO Pharma Limited, has received tentative approval from the US Food & Drug Administration (USFDA) for Olaparib Tablets, 100 mg and 150 mg. This approval is for an Abbreviated New Drug Application (ANDA) that is therapeutically equivalent to AstraZeneca's Lynparza Tablets. Alembic will handle distribution in the U.S., while NATCO will manufacture the product. The U.S. market for Olaparib Tablets is estimated at USD 1.4 billion. This marks Alembic's 20th tentative approval from the USFDA, adding to its total of 244 ANDA approvals.