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Sirturo Approval History

  • FDA approved: Yes (First approved December 28th, 2012)
  • Brand name: Sirturo
  • Generic name: bedaquiline
  • Dosage form: Tablets
  • Company: Janssen Research & Development, LLC
  • Treatment for: Tuberculosis, Resistant

Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug indicated for the treatment of pulmonary multi-drug resistant tuberculosis.

Development History and FDA Approval Process for Sirturo

Dec 31, 2012Approval FDA Approves Sirturo to Treat Multi-Drug Resistant Tuberculosis
Sep  5, 2012U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
Jul  2, 2012Janssen Research & Development Submits New Drug Application to FDA for Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline (TMC207)

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