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Rubraca Approval History

  • FDA approved: Yes (First approved December 19th, 2016)
  • Brand name: Rubraca
  • Generic name: rucaparib
  • Dosage form: Tablets
  • Company: Clovis Oncology, Inc.
  • Treatment for: Ovarian Cancer

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of advanced mutant BRCA ovarian cancer.

Development History and FDA Approval Process for Rubraca

Dec 19, 2016Approval FDA Grants Accelerated Approval to Rubraca (rucaparib) for Advanced Ovarian Cancer
Aug 23, 2016FDA Accepts Clovis Oncology’s NDA for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer
Jun  6, 2016Clovis Oncology Presents Data From Phase 2 Studies of Rucaparib in Advanced Ovarian Cancer and Pancreatic Cancer
May 30, 2015Clovis Oncology’S Phase 2 Studies of Rucaparib in Ovarian Cancer Demonstrate Highly Compelling Clinical Activity

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