Zydus Lifesciences bags tentative USFDA nod for cancer drug Olaparib

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-11-07 12:53 GMT   |   Update On 2025-11-07 12:53 GMT
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Ahmedabad: Zydus Lifesciences Limited 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 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).
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Olaparib 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.

Read also: Zydus gets USFDA Orphan Drug Designation for Desidustat for beta-thalassemia

Zydus Lifesciences Ltd. is a global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and New Chemical Entities.

Read also: Zydus bags Health Canada approval for Mesalamine suppositories for active ulcerative proctitis



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