Cipla said that it has received final approval for an ANDA for its generic version of Bausch’s Migranal dihydroergotamine (DHE) mesylate nasal spray for the treatment of migraine. According to Cipla, this is the company’s first FDA approval for a generic nasal spray; the agency has recently approved an ANDA for Cipla’s generic Proventil HFA.
The FDA approved the ANDA with a competitive generic therapy (CGT) designation, which was established in 2017 for drugs with “inadequate generic competition” and offers 180 days of exclusivity. According to web site GoodRx, which tracks US drug prices, the average retail price of Migranal nasal spray is currently $3,340.46.
Read the Cipla press release.
