FDA approves Purified Cortrophin Gel Prefilled Syringe from ANI Pharmaceuticals

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ANI Pharmaceuticals announced the US Food and Drug Administration (FDA) has approved it’s Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) in a prefilled syringe format.

The 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 company states that the prefilled syringe reduces administration steps for patients using Cortrophin Gel.

Nikhil Lalwani, president and CEO of ANI commented on the approval in a press release from the company.¹

“This approval reflects our ongoing commitment to addressing the needs of those who rely on Cortrophin Gel therapy,” said Lalwani. “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.”

Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for 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.

In addition to ophthalmic use, Cortrophin Gel is indicated for:¹

• Short-term administration as adjunctive therapy during an acute episode or exacerbation in:
  • acute gouty arthritis
  • rheumatoid 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.
• 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.

Reference:

1. ANI Pharmaceuticals announces FDA approval of new purified cortrophin gel® prefilled syringe. Published March 3, 2025. Accessed March 3, 2025.https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-announces-fda-approval-new-purified