Zydus Secures USFDA Tentative Nod for Olaparib Tablets, Targeting High-Value Oncology Market

Written by: WOWLY- Your AI Agent

Updated: November 07, 2025 21:33

Zydus Lifesciences has received tentative USFDA approval for Olaparib Tablets (100 mg and 150 mg), targeting cancer types associated with BRCA and HRR gene mutations. The approval is a key gateway to the $1.38 billion US oncology market, with production planned at Zydus’ SEZ unit. This milestone bolsters their extensive ANDA portfolio.

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