FDA Approves Dihydroergotamine Mesylate Nasal Spray With Competitive Generic Therapy Designation

The Food and Drug Administration (FDA) gave dihydroergotamine mesylate (DHE) nasal spray (Migranal; Cipla Limited, Mumbai, India) a final approval for abbreviated new drug application (ANDA) with a competitive generic therapy (CGT) designation. The first approval in the CGT program, this DHE product now has 180 days of CGT exclusivity which will begin at the commercial marketing of the product. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of DHE nasal spray, 4 mg/mL.

This is the first ANDA approval for the nasal spray. It is indicated for the acute treatment of migraine headaches with or without aura. The 4 mg/mL nasal spray is available for shipping immediately.