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Cipla Ltd on Thursday said it has received final approval from the US health regulator for Dihydroergotamine Mesylate nasal spray, indicated for the treatment of migraine headaches.
“It has received final approval for its Abbreviated New Drug Application (ANDA) for Dihydroergotamine Mesylate nasal spray 4mg/mL from the United States Food and Drug Administration (USFDA) with a competitive generic therapy (CGT) designation,” the company said in a filing to BSE.
An Abbreviated New Drug Application is an application for a US generic drug approval for an existing licensed medication or approved drug.
This is Cipla’s first ANDA approval for a nasal spray. It is indicated for the treatment of acute attacks of migraine headaches with or without aura.
“Cipla is the ‘first approved applicant’ for such CGT 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.
This 180-day CGT exclusivity will not block the commercialisation of the existing approvals of the nasal spray.
“Cipla’s Dihydroergotamine Mesylate Nasal Spray 4mg/mL is AB-rated generic therapeutic equivalent version of Bausch Health US LLC’s Migranal,” the filing said.
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