Cipla gets FDA’s final approval for generic version of Migranal with CGT designation

Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the US Food and Drug Administration (FDA) with a competitive generic therapy (CGT) designation.

The Indian pharma company said that it is the first approved applicant for such CGT and as a result is eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of its product. The 180-day CGT exclusivity will not stop the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL, said the company.

Cipla’s Dihydroergotamine Mesylate Nasal Spray 4mg/mL is an AB-rated generic therapeutic equivalent version of Bausch Health US LLC’s Migranal. The product marks Cipla’s first ANDA approval for a nasal spray, indicated for the acute treatment of migraine headaches with or without aura.

According to IQVIA (IMS Health), Migranal and its authorized generic equivalents had US sales of about $102 million for the 12-month period ending March 2020.

Cipla said that its product is available for shipping with immediate effect.