Posted by Michael Wonder on 21 May 2020
Cipla receives final approval for generic version of Migranal (dihydroergotamine mesylate 4 mg/mL nasal spray) with a competitive generic therapy designation
21 May 2020 - Cipla today announced that it has received final approval for its abbreviated new drug application for dihydroergotamine mesylate 4 mg/mL nasal spray from the US FDA with a competitive generic therapy designation.
Cipla is the first approved applicant for such designation and, is therefore, eligible for 180 days of exclusivity which will begin to run from the commercial marketing of Cipla’s product.
This 180 day exclusivity will not block the commercialisation of the existing approvals of dihydroergotamine mesylate nasal 4 mg/mL nasal spray.
Cipla’s dihydroergotamine mesylate 4 mg/mL nasal spray is AB-rated generic therapeutic equivalent version of Bausch Health US Migranal.
