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Sirturo FDA Approval History

FDA Approved: Yes (First approved December 28, 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 timeline for Sirturo

May 27, 2020Approval FDA Approves New Pediatric Formulation of Sirturo (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis
Aug  9, 2019Approval Janssen Announces U.S. FDA Accelerated Approval for Sirturo (bedaquiline) as Part of Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis
Aug 17, 2018World Health Organization Recommends the Use of Bedaquiline in all Conventional Multidrug-Resistant Tuberculosis Treatment Regimens
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)

Further information

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