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Zejula Approval History

FDA Approved: Yes (First approved March 27, 2017)
Brand name: Zejula
Generic name: niraparib
Dosage form: Capsules
Company: Tesaro Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

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

Development History and FDA Approval Process for Zejula

DateArticle
Mar 27, 2017Approval Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer
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 29, 2016Tesaro's Niraparib Significantly Improved Progression-Free Survival for Patients With Ovarian Cancer in Both Cohorts of the Phase 3 NOVA Trial
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

Further information

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