Cipla receives final USFDA approval for generic version of Shire’s Firazyr

Cipla Limited announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Icatibant Injectable 30mg/3mL from the United States Food and Drug Administration (US FDA).

Cipla’s Icatibant Injectable Pre-Filled Syringe 30mg/3mL is AP-rated generic version of Shire’s Firazyr®. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

According to IQVIA (IMS Health), Firazyr® and its generic equivalents had US sales of approximately $270M for the 12-month period ending May 2020.

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 May’20), 3rd largest in the pharma private market in South Africa (IQVIA MAT May’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.