CF drug approved in US
March 25, 2013
NOVARTIS has announced today
that the US Food and Drug
Administration has approved TOBI
Podhaler (tobramycin inhalation
powder) 28mg per capsule for the
management of cystic fibrosis (CF)
patients with pseudomonas
aeruginosa (Pa) bacteria in the
lungs.
Pa is the leading cause of loss of
lung function in CF patients.
TOBI Podhaler is a new, nonnebulized
formulation and delivery
system of tobramycin, the same
active ingredient as in TOBI
(tobramycin inhalation solution,
USP) 300mg/5 mL, which has been
on the market for approximately 15
years.
TOBI Podhaler is the first and only
FDA-approved dry powder inhaled
antibacterial for Pa in the US.
The drug delivers tobramycin into
the patient's lungs via a pocketsized
dry powder inhaler and offers
better portability than TOBI, which
is administered to the patient using
a nebuliser.
It is not known if TOBI Podhaler is
safe and effective in patients under
six years of age, in those with lung
function outside of a certain range,
or in those whose lungs contain
bacteria called Burkholderia
cepacia.
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