Medication for treating CF

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FDA clears Novartis anti-bacterial inhaler for certain cystic fibrosis patients

Novartis TOBI Podhaler (tobramycin inhalation powder) 28mg per capsule has obtained FDA approval for the treatment of bacterial lung infection in certain cystic fibrosis (CF) patients.

TOBI Podhaler is new non-nebulized formulation and delivery system of tobramycin that is indicated for CF patients with Pseudomonas aeruginosa (Pa) bacteria in the lungs.

The first dry powder formulation approved in the US for Pa, leverages Novartis PulmoSphere technology that facilitates creation of hollow porous particles of tobramycin.

Cystic Fibrosisi Foundation president and CEO Robert Beall said, "TOBI Podhaler helps relieve that burden by shortening the time it takes to administer the medicine and making it easy for people with CF to take their treatment with them wherever they need to go."

Tobramycin, the active ingredient of TOBI Podhaler, is the same ingredient in the existing tobramycin inhalation solution, USP (TOBI) 300mg/5mL.

The new medication does not require refrigeration or power supply for the delivery of tobramycin into patient's lungs using a small dry powder inhaler.

Studies established significant reduction of medication administration time of TOBI Podhaler compared to TOBI.

Novartis Pharmaceuticals president Andre Wyss said, "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."

Source: Pharmaceutical Bussines Review

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