ANI Pharmaceuticals Gains FDA Approval For Prefilled Cortrophin® Gel Syringe To Improve Patient Convenience

The FDA granted ANI Pharmaceuticals permission to introduce the Purified Cortrophin® Gel, a repository of corticotropin injection USP in its prefilled syringe format. Patients will benefit from simpler dosing because the updated version will become available as 40 USP units/0.5 mL and 80 USP units/mL single-dose options for administration. The established speciality pharmacy network of Cortrophin Gel will distribute the prefilled syringes to patients.

Nikhil Lalwani, President and Chief Executive Officer of ANI, said, “Our new prefilled syringe reduces the steps required for patients to administer Cortrophin Gel treatment. This approval reflects our ongoing commitment to addressing the needs of those who rely on Cortrophin Gel therapy. We look forward to making the Cortrophin Gel prefilled syringe available in the second quarter of 2025 as we continue to advance our Rare Disease portfolio.”

The prefilled syringe method cuts down administration steps so patients who need Cortrophin Gel treatment can experience better convenience. The medicine will still be available in 5 mL and 1 mL vial-format Cortrophin Gel despite the new prefilled syringe option.