Cipla bags USFDA nod for Sumatriptan Nasal Spray to treat migraine
Mumbai: Drugmaker, Cipla Limited, today announced that the company has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mg from the United States Food and Drug Administration (USFDA).
Cipla's Sumatriptan Nasal Spray USP, 20 mg is an AB-rated generic therapeutic equivalent version of GlaxoSmithKline's Imitrex Nasal Spray.
Imitrex Nasal Spray is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.
According to IQVIA (IMS Health), Imitrex Nasal Spray 20mg and its generic equivalents had US sales of approximately $53.3M for the 12-month period ending December 2020.
Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.