www.fdanews.com/articles/197275-cipla-receives-approval-for-generic-migranal
Cipla Receives Approval for Generic Migranal
May 26, 2020
Cipla has received the FDA’s approval for its generic of Bausch’s Migranal (dihydroergotamine mesylate nasal spray 4mg/mL) for the acute treatment of migraine headaches with or without aura.
The FDA has also granted the product a competitive generic therapy (CGT) designation.
The CTG designation qualifies the company for 180 days of exclusivity, which will begin at the commercial marketing of the product.