ANI Pharmaceuticals announced U.S. Food and Drug Administration approval of a prefilled syringe format for Purified Cortrophin Gel (repository corticotropin injection USP), available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options.

The novel prefilled syringe is designed to simplify administration in patients and will be distributed through the Cortrophin Gel specialty pharmacy network, according to a press release from ANI Pharmaceuticals. The previously available 5 mL and 1 mL vial formulations will remain on the market. The company anticipates that the new format will be available in the second quarter of 2025.

The novel drug is indicated for acute exacerbations of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis as well as systemic lupus erythematosus and systemic dermatomyositis. It is also approved for ophthalmic, dermatologic, allergic, nephrotic, and neurologic conditions, including multiple sclerosis exacerbations and symptomatic sarcoidosis. The drug is administered subcutaneously or intramuscularly.

Contraindications include systemic fungal infections, ocular herpes simplex, congestive heart failure, recent surgery, and primary adrenocortical insufficiency. The injection is not approved for intravenous administration and should not be used in patients with hypersensitivity to porcine-derived proteins.

Adverse effects may include fluid retention, muscle weakness, osteoporosis, hypertension, injection site reactions, mood alterations, and immunosuppression. Prolonged use may increase the risk of adrenal insufficiency, posterior subcapsular cataracts, and glaucoma. Close monitoring was recommended in patients with comorbid conditions, including diabetes and renal insufficiency.

The novel drug may affect immune responses to vaccination and is contraindicated with smallpox vaccination. Caution was advised when coadministering aspirin in patients with hypoprothrombinemia. Use during pregnancy should be limited to cases where the benefits outweigh potential risks.