New Delhi: Alembic Pharmaceuticals said its partner NATCO Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Olaparib Tablets in 100 mg and 150 mg strengths, a generic equivalent of AstraZeneca's Lynparza tablets.
The approval is for the indication covered under the approved labelling of the reference listed drug. Alembic Pharmaceuticals will distribute the product in the United States, while NATCO Pharma will manufacture the tablets.
