It took many years, but Johnson & Johnson’s tuberculosis med Sirturo can finally claim full approvals in the U.S. and Europe following initial conditional nods. nnRegulators on both sides of the Atlantic granted the full approvals based on data from a phase 3 study showing that a Sirturo-containing regimen delivered a “significant improvement” in treatment outcomes compared to other, injectable-containing regimens, according to a recent company press release. The STREAM Stage 2 study was the first large-scale trial to evaluate an all-oral Sirturo-based regimen.
The National Pharmaceutical Pricing Authority (NPPA) has invoked the Para 3 of the Drugs (Prices Control) Order, 2013, and directed Mumbai-based Macleods Pharmaceuticals to supply anti-tuberculosis drug rifampicin 150 mg and 450 mg capsules to the central procurement agency Central Medical Services Society (CMSS).
Enforcement Report - Week of April 17, 2024
Leading generic drug makers Lupin, Glenmark, and Natco Pharma are recalling products in the American market for manufacturing issues, according to the US health regulator.
Enforcement Report - Week of February 7, 2024
Fighting tuberculosis: EUROAPI’s rifampicin API meets new requirements for nitrosamine impurity standards
Enforcement Report - Week of June 7, 2023
Enforcement Report - Week of January 25, 2023
Enforcement Report - Week of January 18, 2023
Enforcement Report - Week of October 26, 2022