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ANI Pharmaceuticals Announces FDA Approval of New Purified Cortrophin Gel® Prefilled Syringe
PRINCETON, N.J., March 03, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced U.S. Food and Drug
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":"PRINCETON, N.J., March 03, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in a prefilled syringe format. This new presentation will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network. The prefilled syringe reduces administration steps for patients using Cortrophin Gel, which remains available in 5 mL and 1 mL vials. For full indications and important safety information, please see below. “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,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. “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.” IndicationsCortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for: Short-term administration as an adjunctive therapy during an acute episode or exacerbation in: acute gouty arthritisrheumatoid arthritis, including juvenile rheumatoid arthritis; psoriatic arthritis; and ankylosing spondylitis. Exacerbations or as maintenance therapy in select cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis).Severe erythema multiforme (Stevens-Johnson syndrome) and severe psoriasis.Atopic dermatitis and serum sickness.Severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa, such as allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.Symptomatic sarcoidosis.Inducing a diuresis or remission of proteinuria due to nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.Acute exacerbations of multiple sclerosis. Important Safety Information Contraindications Cortrophin Gel is contraindicated for intravenous administration.Cortrophin Gel is contraindicated in patients wh...