Sirturo FDA Approval History

Last updated by Judith Stewart, BPharm on June 25, 2024.

FDA Approved: Yes (First approved December 28, 2012)
Brand name: Sirturo
Generic name: bedaquiline
Dosage form: Tablets
Company: Johnson & Johnson Innovative Medicine
Treatment for: Tuberculosis, Resistant

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

Sirturo is indicated as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid.

Development timeline for Sirturo

Date	Article
Jun 21, 2024	Approval FDA Converts Tuberculosis Treatment Sirturo to Traditional Approval
May 27, 2020	Approval FDA Approves New Pediatric Formulation of Sirturo (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis
Aug 9, 2019	Approval 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, 2018	World Health Organization Recommends the Use of Bedaquiline in all Conventional Multidrug-Resistant Tuberculosis Treatment Regimens
Dec 31, 2012	Approval FDA Grants Accelerated Approval for Sirturo to Treat Multi-Drug Resistant Tuberculosis
Sep 5, 2012	U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
Jul 2, 2012	Janssen Research & Development Submits New Drug Application to FDA for Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline (TMC207)

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA