Zydus receives USFDA tentative approval for cancer treatment Olaparib

Zydus Lifesciences Limited announced on November 7, 2025, that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Olaparib Tablets, in 100 mg and 150 mg strengths. These tablets, an equivalent to Lynparza Tablets, are indicated for treating specific types of ovarian, breast, pancreatic, and prostate cancers linked to genetic mutations in the BRCA gene or other homologous recombination repair (HRR) genes.

Olaparib tablets recorded annual sales of $1,379.4 million in the United States as of September 2025 (IQVIA MAT). This approval marks another achievement for Zydus, bringing their total approvals to 426.

The group has filed 487 Abbreviated New Drug Applications (ANDAs) since initiating its filing process in fiscal year 2003-04, reflecting a sustained focus on expanding its generic pharmaceutical portfolio.