April 16 U.S. health regulators rejected
Allergan Inc's inhaled migraine drug, citing issues
related to the company's canister filling unit.
The company, whose injectible wrinkle-filler Botox was
approved for headaches in October 2010, said the main issues
cited in the complete response letter were already identified by
the regulator in prior discussions with Allergan.
Allergan estimates the next regulatory action on the
migraine drug, Levadex, to occur by the end of the fourth
quarter of 2013.
The drug is an inhaled version of an existing drug,
dihydroergotamine, which is typically administered by injection
or nasal spray at a headache center or hospital.