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- The FDA has approved DifGen Pharmaceuticals' ANDA for Epinephrine Injection USP, 1 mg/mL single-dose vials, the second generic version of Adrenalin Injection. - The product is bioequivalent and therapeutically equivalent to the reference listed drug Adrenalin Injection, 1 mg/mL, held under NDA 204200. - DifGen said the approval adds another source of the emergency medicine for the US market and advances its sterile injectable portfolio strategy. - Epinephrine is described by the company as an important emergency medicine used in acute clinical settings such as hospitals.
- The FDA has issued a "study may proceed" letter for DifGen's DFGN-101, an intramuscular injection for advanced or metastatic breast cancer in women. - DFGN-101 is designed as a single injection, potentially reducing the treatment burden compared to the currently marketed two-injection reference product. - The development pathway does not require a clinical endpoint efficacy study, supported by CMC data and a pilot PK study showing comparable profile to the reference product. - DifGen will proceed with preclinical toxicology studies in rat and rabbit models and a Phase 1 pharmacokinetic study.
