FDA approves generic tobramycin inhalation solution

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FDA approves generic tobramycin inhalation solution

Genéricos/Novedades | Posted 31/10/2013 0 Post your comment

Teva Pharmaceutical Industries (Teva) announced on 14 October 2013 that the US Food and Drug Administration (FDA) had granted approval for its abbreviated new drug application (ANDA) for tobramycin inhalation solution.

The drug is a generic equivalent to Tobi, which is an inhaled antibiotic for treating lung infections in patients with cystic fibrosis and which is produced by Novartis.

Pursuant to an agreement with Novartis, Teva expects to launch its generic version in late November 2013. As of 30 June 2013, Tobi had annual sales of approximately US$350 million in the US, according to IMS data.

The news could possibly go some way to alleviating shortages of tobramycin. The injectable form of the drug has been in short supply for some time, according to both the American Society of Health-System Pharmacists (ASHP) and FDA. Suppliers of tobramycin injection, APP, Hospira, Pfizer and Teva, have all reported problems with supplying the drug.

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Source: ASHP, FDA, Teva