Zydus Lifesciences secures FDA tentative approval for Olaparib tablets

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Olaparib Tablets, 100 mg and 150 mg (USRLD: Lynparza Tablets, 100 mg and 150 mg).

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers in patients who have specific genetic mutations, specifically in the BRCA gene or other homologous recombination repair (HRR) genes. The tablets will be manufactured at Zydus Lifesciences Ltd, SEZ.

Olaparib tablets recorded annual sales of $1,379.4 million in the United States, according to IQVIA MAT for September 2025. The group now has 426 approvals and has filed 487 ANDAs since the commencement of the filing process in FY 2003–04.