DifGen Pharmaceuticals has announced that the US Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Epinephrine Injection USP, 1 mg/mL, single-dose vials. The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Adrenalin Injection, 1 mg/mL, (NDA 204200).

DifGen's product represents the second generic approval to the RLD, providing an additional source of Epinephrine Injection USP, 1 mg/mL, single-dose vials for the US market.

Epinephrine is an important emergency medicine used in acute clinical settings. The approval represents another milestone in DifGen's strategy to build a differentiated portfolio of injectable products for the US market, with a focus on medicines that are important to hospitals, healthcare providers and patients.

The approval further strengthens DifGen's growing US portfolio and reflects the company's continued investment in the development and commercialisation of complex and differentiated pharmaceutical products across multiple dosage forms, including sterile injectables.

DifGen's integrated approach brings together product selection, formulation and process development, regulatory execution, manufacturing and commercialisation, with the objective of providing a reliable supply of high-quality medicines to the US healthcare market.

DifGen's Epinephrine Injection USP, 1 mg/mL is supplied in single-dose vials and has been approved by the FDA as bioequivalent and therapeutically equivalent to Adrenalin Injection, 1 mg/mL, of PH Health.