Zydus Lifesciences gets USFDA tentative Nod for Olaparib Tablets

Zydus Lifesciences announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Olaparib Tablets, used in the treatment of certain cancers.

Olaparib is indicated for the treatment of ovarian, breast, pancreatic, and prostate cancers in patients with specific genetic mutations, particularly those in the BRCA gene or other homologous recombination repair (HRR) genes. The drug will be manufactured at Zydus Lifesciences SEZ facility.

The approved product is bioequivalent to Lynparza Tablets (100 mg and 150 mg), which recorded annual sales of $1,379.4 million in the United States, according to IQVIA MAT data for September 2025.

 

With this approval, Zydus Lifesciences total tally now stands at 426 approvals, from a cumulative 487 ANDA filings since the company began the process in FY 200304.

The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives.

Zydus Lifesciences reported 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26.

The counter shed 0.03% to Rs 943.50 on the BSE.

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