US FDA approves Teva’s generic TOBI

Israel-based global generics leader Teva Pharmaceutical Industries (NYSE: TEVA) says that the US Food and Drug Administration has granted approval of the generic equivalent to cystic fibrosis drug TOBI (tobramycin inhalation solution USP) in the USA.

Under an agreement with Swiss pharma major Novartis (NOVN: VX) on this product, Teva expects to launch this product in late November. Marketed by Novartis, TOBIhad annual sales of around $350 million in the USA, according to IMS data as of June 30, 2013 quoted by Teva.

Although the basic TOBI product has been on the market for many years, this year the FDA approved Novartis’ TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.