Drug major Cipla on Tuesday said it has received final approval from the United States Food and Drug Administration (USFDA) for Icatibant Injectable, indicated for treatment of acute attacks of hereditary angioedema – a rare genetic condition – in adults.
Cipla’s Icatibant injectable pre-filled syringe in the strength of 30mg/3mL is generic version of Shire’s Firazyr, the company said in a regulatory filing. The firm said “it has received final approval for its abbreviated new drug application for Icatibant Injectable 30mg/3mL from the United States Food and Drug Administration”.
Quoting IQVIA (IMS Health) data, Cipla said Firazyr and its generic equivalents had US sales of approximately USD 270 million for the 12-month period ending May 2020. Shares of Cipla were trading 0.49 per cent higher at Rs 641.25 apiece on the BSE.