Cipla receives final approval for generic version of Migranal(Dihydroergotamine Mesylate Nasal Spray) with a Competitive Generic Therapy Designation
It is indicated for the acute treatment of migraine headaches with or without aura
Mumbai: Cipla Limited has announced that it has received final approval for its Abbreviated New Drug Application ("ANDA") for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U.S. FDA) with a Competitive Generic Therapy ("CGT") designation.
Cipla is the "first approved applicant" for such CGT and, is, therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla's product. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL.
Cipla's Dihydroergotamine Mesylate Nasal Spray 4mg/mL is an AB-rated generic therapeutic equivalent version of Bausch Health US LLC's Migranal®. This is Cipla's first ANDA approval for a nasal spray. It is indicated for the acute treatment of migraine headaches with or without aura.
According to IQVIA (IMS Health), Migranal® and its authorized generic equivalents had U.S. sales of approximately $102M for the 12-month period ending March 2020.
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.
Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.
Cipla has 34 manufacturing units in 8 locations across India and a presence in over 80 countries.