The FDA has approved Novartis’s TOBI Podhaler tobramycin inhalation powder for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. The agency’s Anti-Infective Drugs Advisory Committee (AIDAC) voted in favor of approval of the dry powder inhaler in September 2012.
According to Novartis, the product will be available in the second quarter of 2013. In the UK, TOBI Podhaler was launched in September 2011.
FDA Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research Edward Cox commented, “Today’s approval broadens the available delivery mechanism options for patients with cystic fibrosis who require treatment for P. aeruginosa. This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler.”
“TOBI Podhaler is an example of how Novartis is utilizing innovative technologies to better meet the needs of patients,” said Novartis Pharmaceuticals President André Wyss. “By eliminating the need for a nebulizer to deliver tobramycin and providing a small, lightweight design, TOBI Podhaler reduces administration time and improves portability for patients on-the-go. It also underscores our long-term commitment to the cystic fibrosis community.”
Read the Novartis press release.
Read the FDA press release.
