ANI Pharmaceuticals Announces FDA Approval of New Purified Cortrophin Gel® Prefilled Syringe

Core Viewpoint - ANI Pharmaceuticals, Inc. has received FDA approval for a new prefilled syringe format of Purified Cortrophin® Gel, enhancing patient administration convenience and reflecting the company's commitment to rare disease therapies [1][2]. Product Details - The new prefilled syringe will be available in two single-dose options: 40 USP units/0.5 mL and 80 USP units/mL, alongside existing vial formats of 5 mL and 1 mL [1]. - Cortrophin Gel is indicated for various conditions, including acute gouty arthritis, rheumatoid arthritis, systemic lupus erythematosus, and severe allergic and inflammatory conditions [4]. Company Overview - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing and commercializing innovative therapeutics, particularly in rare diseases, ophthalmology, rheumatology, nephrology, neurology, and pulmonology [6]. - The company aims for sustainable growth through its Rare Disease business, Generics business, and Brands business [6].