Cipla Receives Final Approval for Generic Version of IMITREX® (Sumatriptan Nasal Spray, 20 mg) from GlaxoSmithKline

Mumbai, Indien (ots/PRNewswire) Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereafter “Cipla”) announced today that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Sumatriptan nasal spray, 20 mg.

Sumatriptan Nasal Spray USP, 20 mg from Cipla is a generic, therapeutically equivalent version of Imitrex® nasal spray from GlaxoSmithKline with an AB rating.

Imitrex® nasal spray is a serotonin (5-HT1B / 1D) receptor agonist (triptan), which is indicated for the acute treatment of migraines with or without aura in adults.

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

Information 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 and North America, as well as in key regulated and emerging markets. Our strengths in respiratory diseases, antiretroviral drugs, urology, cardiology, anti-infectives and CNS are well known. Our 46 production 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 80+ markets. Cipla is the third largest pharmaceutical company in India (IQVIA MAT December ’20), the third largest in the private pharmaceutical market in South Africa (IQVIA MAT December ’20) and is one of the top-selling generic medicines in the US. For over eight decades, a dedication to the patient has inspired every aspect of Cipla’s work. Our paradigm-changing offering of triple antiretroviral therapy for HIV / AIDS for less than $ 1 a day in Africa in 2001 is widely recognized as a contribution to putting inclusion, accessibility and affordability at the heart of the HIV movement. As a responsible company, Cipla takes a humanitarian approach to health care and is a preferred partner for global health organizations, peers and all stakeholders through its deeply rooted connections with the communities in which it operates. For more, please visit, or click on Twitter, Facebook, LinkedIn.


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