Slayback Pharma wins FDA approval of Icatibant Injection 30 mg/3 ml (10 mg/ml)
3 September 2020 -

Pharmaceutical company Slayback Pharma LLC reported on Wednesday the receipt of final approval from the US Food and Drug Administration (FDA) for its ANDA for Icatibant Injection 30 mg/3 ml (10 mg/ml) in a Prefilled Syringe for treating acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Icatibant Injection is the generic equivalent of Firazyr.

Angioedema (which can include swelling of the throat or larynx) can be life-threatening. HAE is an inherited condition characterized by recurrent episodes of nonpruritic, nonpitting, subcutaneous or submucosal swelling without the presence of urticarial lesions. Multiple areas of the body can be involved including hands, feet, intestinal wall, genitalia, face, tongue or larynx. Swelling of the pharynx or larynx can be life-threatening due to asphyxia.