Alembic, NATCO Receive USFDA Tentative Approval for Generic Cancer Drug Olaparib
Mumbai: Alembic Pharmaceuticals Limited (Alembic) has announced that its Partner NATCO Pharma Limited (NATCO) has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olaparib Tablets, 100 mg and 150 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lynparza Tablets, 100 mg and 150 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca) for the indication in the approved labelling. Alembic will distribute the product in the U.S., and its partner NATCO will manufacture Olaparib Tablets, 100 mg and 150 mg.
The Para IV litigation is on-going. Olaparib Tablets, 100 mg and 150 mg, have an estimated market size of approximately USD 1.4 billion in the U.S. for twelve months ending March 2026, according to IQVIA.
Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from USFDA.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a field force of over 5500 are well recognized by doctors and patients.
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