Zydus receives tentative approval from USFDA for Olaparib Tablets, 100 mg and 150 mg

Zydus Lifesciences Ltd has received tentative approval from the USFDA for Olaparib Tablets, 100 mg and 150 mg (USRLD: Lynparza Tablets, 100 mg and 150 mg). Olaparib is indicated for treatment of certain types of ovarian, breast, pancreatic, and prostate cancers in patients who have specific genetic mutations. The tablets will be produced at Zydus Lifesciences Ltd, SEZ. Olaparib tablets had annual sales of USD 1,379.4 mn in the United States (IQVIA MAT Sept-2025). The group now has 426 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.