Purified Cortrophin Gel

NDA 8975, held by Ani Pharms. Corticotropin.

As of Nov 14, 2026, NDA 8975 (Purified Cortrophin Gel), held by Ani Pharms, was first approved by FDA on Jun 16, 1954, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 16, 1954
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Purified Cortrophin Gel is indicated in the following disorders: 1. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute gouty arthritis. 2. Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). 3. Dermatologic diseases: Severe erythema multiforme (Stevens-Johnson syndrome). Severe psoriasis. 4.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 16, 1954	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Purified Cortrophin Gel40 UNITS/ML · injectable;injection	Corticotropin	Discontinued
Purified Cortrophin Gel80 UNITS/ML · injectable;injection	Corticotropin	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Oct 5, 2026	Supplement 24Labeling · Standard review	Approved	Label Letter
Feb 28, 2025	Supplement 16Manufacturing	Approved	Label Letter
Dec 13, 2024	Supplement 15Labeling · Standard review	Approved	Label Letter
Oct 26, 2023	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 29, 2021	Supplement 8Manufacturing	Approved	Review
Dec 8, 1977	Supplement 6Labeling	Approved	None posted
May 25, 1977	Supplement 5Labeling	Approved	None posted
Jun 16, 1954	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 8975
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters