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
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).
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
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.