Cipla gets final approval from USFDA for rare genetic condition treatment drug
14 july: Cipla on Tuesday said that it has received final acceptance in the United States Food and Drug Administration (USFDA) to Icatibant Injectable, suggested for treatment of acute attacks of hereditary angioedema – a rare genetic disease – from adults.
Cipla’s Icatibant injectable pre-filled syringe at the potency of 30mg/3mL is generic version of Shire’s Firazyr,” the company stated in a regulatory filing.
The company said “it’s received final approval for its abbreviated new drug application for Icatibant Injectable 30mg/3mL in the United States Food and Drug Administration”.
Quoting IQVIA (IMS Health) information, Cipla stated Firazyr and its generic equivalents had US sales of about USD 270 million to its 12-month period end May 2023.
Stocks of Cipla were investing 0.49 percent higher at Rs 641.25 apiece over the BSE.