Cipla Gets Final Approval for Generic Version of GlaxoSmithKline's IMITREX

Cipla Limited 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 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 USD 53.3M for the 12-month period ending December 2020.