Cipla receives final USFDA approval for generic version of Shire’s Firazyr® (Icatibant Injectable Pre-Filled Syringe 30mg/3mL)
Mumbai, India; July 14, 2020: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") today 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.