Skip to Content

Niraparib Approval Status

Niraparib is an oral, poly ADP-ribose polymerase (PARP) inhibitor in development for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Development Status and FDA Approval Process for niraparib

Dec 20, 2016Tesaro Announces Priority Review Designation for Niraparib NDA
Nov  1, 2016Tesaro Announces Submission of Niraparib NDA For Platinum-sensitive, Recurrent Ovarian Cancer
Sep 12, 2016Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission
Jun  4, 2013Tesaro and the European Network of Gynecological Oncological Trial Groups Forge Partnership to Develop Niraparib for Ovarian Cancer
Jun  4, 2013TESARO Details Niraparib Phase 1 Clinical Data Presented at the 2013 ASCO Annual Meeting

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.