Cipla receives final approval for generic version of GlaxoSmithKline’s IMITREX®
Mumbai, India, March 02, 2021: Cipla Limited (BSE: 500087; NSE: CIPLA EQ hereinafter referred to as “Cipla”) today announced that it 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 (U.S. FDA).
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.