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

Cipla 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.