The U.S. Food and Drug Administration has approved Cipla Ltd.'s Dihydroergotamine Mesylate nasal spray, indicated for the treatment of migraine, the Indian drugmaker said on Thursday.
This is Cipla's first Abbreviated New Drug Application approval for a nasal spray. It is indicated for the treatment of acute attacks of migraine headaches with or without aura. An Abbreviated New Drug Application is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.
"Cipla is the 'first approved applicant' for such Competitive Generic Therapy and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla's product," it said in a regulatory filing.
This 180-day CGT exclusivity will not block the commercialisation of existing approvals of the nasal spray. "Cipla's Dihydroergotamine Mesylate Nasal Spray 4mg/mL is AB-rated generic therapeutic equivalent version of Bausch Health U.S. LLC's Migranal," according to the filing.
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