December 17, 2015 – TAG and the TB CAB signed on to open letters to several manufacturers of U.S. Food and Drug Administration (FDA)-approved generic linezolid, including Pfizer, Teva, Glenmark, Alkem, Amneal, Macleods, Apotex, Hetero, and Sanofi urging the companies to register their respective linezolid products with the Medicines Control Council (MCC) in South Africa. Registration of additional linezolid products will address the existing effective market monopoly and extremely high prices that prevent linezolid from being offered to all patients who could benefit from its use in South Africa and countries like Swaziland that rely on the South African regulatory approval system. The co-signatories asked that following registration, companies provide linezolid at the price currently offered to country programs through the Global Drug Facility (GDF).
TAG and TB CAB Letters Urging Pharmaceutical Companies to Register Their Respective Linezolid Products with the Medicines Control Council (MCC) in South Africa