Category: Approval/Launch Region: Asia · India Company: Cipla Ltd

Cipla Receives US FDA Approval For Generic Imitrex

Cipla Receives US FDA Approval For Generic Imitrex
Cipla Limited 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 (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 $53.3 million for the 12-month period ending December 2020.

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