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Talazoparib Capsules Quality Review by Ramani is a document available to read on EtoBox.

The NDA 211651 for Talazoparib capsules has been recommended for approval based on a comprehensive review of product quality, including manufacturing facilities and processes. Talazoparib is indicated for adult patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer, with a recommended dose of 1 mg taken orally once daily. The quality assessment confirms that there are no outstanding product quality issues, and the proposed specifications and stability data are accepta

Author

Ramani

Language

EN