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Generic Tobi (Tobramycin) Gets FDA Nod

Launch expected in November (October 14)

The FDA has granted approval to the generic equivalent of Tobi (tobramycin inhalation solution). The generic version, marketed by Teva Pharmaceutical Industries, is expected to be launched in late November.

As a brand-name product, Tobi (Novartis) had annual sales of approximately $350 million in the U.S., according to IMS data as of June 30, 2013.

Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis, leading to altered cell membrane permeability, progressive disruption of the cell envelope, and eventual cell death. The drug is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa infection.

Sources: Teva Pharma; October 14, 2013; and Novartis; September 2013.

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