Cipla receives final approval for generic version of GlaxoSmithKline's IMITREX® (Sumatriptan Nasal Spray, 20 mg)
Cipla Limited has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for the 20 mg Sumatriptan Nasal Spray. This product is a generic version of GlaxoSmithKline's Imitrex® Nasal Spray, indicated for the acute treatment of migraines in adults. According to IQVIA, the U.S. sales of Imitrex Nasal Spray and its generics reached approximately $53.3 million in the year ending December 2020. Cipla aims to leverage this approval to expand its presence in the migraine treatment market.
- Final FDA approval for Sumatriptan Nasal Spray opens a significant market opportunity.
- Potential to capture part of the $53.3 million U.S. sales from Imitrex Nasal Spray.
- None.
MUMBAI, India, March 2, 2021 /PRNewswire/ -- 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
About Cipla:
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT December' 20), 3rd largest in the pharma private market in South Africa (IQVIA MAT December'20), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.
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SOURCE Cipla
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