Zydus Lifesciences has received tentative approval from the USFDA for Olaparib Tablets, 100 mg and 150 mg. These tablets are indicated for the treatment of specific types of ovarian, breast, pancreatic, and prostate cancers in patients with particular genetic mutations. Olaparib tablets had annual sales of USD 1,379.4 mn in the United States (IQVIA MAT Sept-2025).
USFDA Tentative Approval
Zydus Lifesciences Limited has secured tentative approval from the United States Food and Drug Administration (USFDA) for its Olaparib Tablets, available in 100 mg and 150 mg dosages. This approval, announced on November 7, 2025, marks a significant step in expanding the company’s portfolio of oncology treatments.
Olaparib Tablets Overview
Olaparib is prescribed for treating certain types of cancers, including ovarian, breast, pancreatic, and prostate cancers, specifically in patients with genetic mutations like the BRCA gene or other homologous recombination repair (HRR) genes. According to the announcement, Olaparib tablets recorded annual sales of USD 1,379.4 mn in the United States as of September 2025 (IQVIA MAT).
Strategic Growth
With this latest development, Zydus Lifesciences now holds 426 approvals and has filed 487 ANDAs since the commencement of its filing process in FY 2003-04. The production of Olaparib tablets will take place at Zydus Lifesciences Ltd, SEZ.
Source: BSE
