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FDA rejects Allergan migraine drug on manufacturing issues
April 16, 2013 / 1:30 PM / 5 years ago

FDA rejects Allergan migraine drug on manufacturing issues

April 16 (Reuters) - 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.

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