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Alexza Pharmaceuticals, Inc.
ALXA and Grupo Ferrer Internacional,
S.A., today announced that the European Commission has granted marketing
authorization for ADASUVE ( Staccato loxapine). In the European Union (EU),
ADASUVE, 4.5 mg and 9.1 mg inhalation powder loxapine, pre-dispensed, is
authorized for the rapid control of mild-to-moderate agitation in adult
patients with schizophrenia or bipolar disorder.
The ADASUVE marketing authorization requires that patients receive regular
treatment immediately after control of acute agitation symptoms, and that
ADASUVE is administered only in a hospital setting under the supervision of a
healthcare professional. Short-acting beta-agonist bronchodilator treatment
should be available for treatment of possible severe respiratory side-effects
(bronchospasm).
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