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Teva Gets TOBI Approval

To launch Novartis lung drug in November

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Teva Pharmaceutical Industries Ltd. has received approval from the FDA for the generic equivalent to TOBI (Tobramycin Inhalation Solution USP) in the U.S.

Teva expects to launch this product in late November, as per its agreement with Novartis on this product. TOBI had annual sales of approximately $350 million for Novartis in the U.S., according to IMS data. TOBI is used to treat people with cystic fibrosis who have a persistent lung infection with Pseudomonas aeruginosa.

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