Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) as part of combination therapy in adult and paediatric patients (5 years and older and weighing at least 15 kg) with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid.
With the FDA’s approval, label restrictions that were included when the medicine was granted accelerated approval in the US in December 2012 are removed.
