- Approval covers 100 mg and 150 mg strengths; drug used in treating ovarian, breast, pancreatic and prostate cancers
- With this, Zydus strengthens its oncology portfolio, taking total USFDA approvals to 426 since FY 2003-04
NE BUSINESS BUREAU
AHMEDABAD, NOV 7
Zydus Lifesciences Limited announced on Thursday that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Olaparib Tablets, 100 mg and 150 mg, a generic version of Lynparza Tablets (reference listed drug).
Olaparib, a targeted therapy drug, is used for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers in patients with specific genetic mutations — particularly in the BRCA gene or other homologous recombination repair (HRR) genes. The drug will be manufactured at Zydus Lifesciences Ltd’s Special Economic Zone (SEZ) facility.
According to IQVIA MAT data (September 2025), Olaparib tablets recorded annual sales of USD 1,379.4 million in the U.S. market, underscoring the significance of this approval in the growing oncology segment.
With this latest approval, Zydus Lifesciences now holds 426 USFDA approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since initiating its filing program in FY 2003–04.
This milestone reinforces Zydus’s commitment to expanding access to advanced therapies and strengthening its position in the global oncology space.
