Cipla receives final approval for generic version of IMITREX® from GlaxoSmithKline (Sumatriptan Nasal Spray, 20 mg)

Mumbai, India, March 2, 2021 /PRNewswire/ — Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereafter referred to as “Cipla”) announced today 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 (US FDA).

Cipla’s Sumatriptan USP Nasal Spray, 20 mg is a generic AB rated therapeutic equivalent version of GlaxoSmithKline’s Imitrex® Nasal Spray.

Imitrex® Nasal Spray is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.

According to IQVIA (IMS Health), Imitrex® Nasal Spray 20mg and its generic equivalents achieved US sales of approximately $53.3M for the 12 month period ending December 2020.

About Cipla:

Founded in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics and portfolio deepening in our home markets of India, South Africa, North America, and major regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urological, cardiological, anti-infective and CNS segments are recognized. Our 46 manufacturing sites around the world produce more than 50 dosage forms and more than 1,500 products using state-of-the-art technology platforms to serve our more than 80 markets. Cipla is ranked 3rd pharma in India (IQVIA MAT on December 20), 3rd largest private pharmaceutical market in South Africa (IQVIA MAT December 2020), and is among the most distributed generic players in the United States For more than eight decades, making a difference for patients has inspired every aspect of Cipla’s work. Our breakthrough offering of triple antiretroviral therapy for HIV/AIDS for less than a dollar a day in Africa in 2001 is widely recognized as having helped put inclusiveness, accessibility and affordability at the center of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to health in pursuit of its goal of “Caring for Life” and deep-rooted community ties wherever it operates make it a partner of choice for global health organizations, peers and all stakeholders. To learn more, please visit www.cipla.comor click on Twitter, Facebook, LinkedIn.


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