This section highlights FDA-related milestones and regulatory updates for drugs developed by ANI Pharmaceuticals (ANIP).
Over the past two years, ANI Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Cortrophin, L-Glutamine, and Naproxen. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Cortrophin Gel - FDA Regulatory Timeline and Events
Cortrophin Gel is a drug developed by ANI Pharmaceuticals for the following indication: Injectable Gel.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cortrophin Gel
- Announced Date:
- June 12, 2025
- Indication:
- Injectable Gel
Announcement
ANI Pharmaceuticals, Inc. announced new preclinical data on the use of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) in a mouse model of murine collagen-induced inflammatory arthritis.
AI Summary
ANI Pharmaceuticals recently presented new preclinical data at the EULAR 2025 Congress. In a mouse model of collagen-induced inflammatory arthritis, the study examined the effects of Purified Cortrophin Gel, also known as repository corticotropin injection USP. The findings showed that the treatment reduced joint swelling and lowered the inflammatory cytokine response in a dose-dependent manner, with the 400 U/kg dose having the strongest effect. Importantly, the treatment did not lead to increased bone turnover or interfere with the formation of immunoglobulin G. Researchers led by Dr. Maripat Corr and Dr. Nancy Lane highlighted that these results expand the understanding of Cortrophin Gel’s mechanism of action. This study supports further exploration of Cortrophin Gel as a potential treatment for inflammation in arthritis, aiming to benefit patients by mitigating joint damage without additional adverse skeletal effects.
Read Announcement- Drug:
- Cortrophin Gel
- Announced Date:
- May 22, 2025
- Indication:
- Injectable Gel
Announcement
ANI Pharmaceuticals, Inc. announced the initiation of a Phase 4 clinical trial at Massachusetts General Hospital to compare the safety and efficacy of two dose levels (40 USP units and 80 USP units) of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) for the treatment of acute gout flares.
AI Summary
ANI Pharmaceuticals has started a Phase 4 clinical trial at Massachusetts General Hospital to study Purified Cortrophin Gel for treating acute gout flares. The trial, led by Dr. Hyon Choi, will compare two dose levels—40 USP units and 80 USP units—to evaluate their safety and effectiveness among patients who did not respond well to standard treatments.
The study is designed as a randomized, double-blind trial with a single injection followed by a 7-day follow-up period. Researchers will assess changes in pain intensity using a Visual Analog Scale and monitor the time to onset of effect and overall patient response. The goal is to generate significant scientific data to help doctors decide the best dosing strategy for managing acute gout flares, potentially offering improved pain relief and care options for patients suffering from this condition.
Read Announcement- Drug:
- Cortrophin Gel
- Announced Date:
- May 5, 2025
- Indication:
- Injectable Gel
Announcement
ANI Pharmaceuticals, Inc. announced preclinical data on the use of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in an EAU mouse model.
AI Summary
ANI Pharmaceuticals recently shared promising preclinical data on the use of Purified Cortrophin® Gel in an experimental autoimmune uveitis (EAU) mouse model. In the study presented at the ARVO 2025 annual meeting, mice were given four different doses of the gel (4, 40, 160, and 400 U/kg). The results showed a clear, dose-dependent reduction in inflammation. The highest dose, 400 U/kg, provided the strongest suppression of EAU and significantly reduced levels of inflammatory molecules, while also protecting against retinal damage.
Dr. Mary Pao emphasized that the gel worked by lowering cytokine production without triggering any harmful immune responses. This study adds to the growing evidence of Cortrophin Gel’s potential therapeutic benefits, supporting further research into its use for inflammatory eye conditions like autoimmune uveitis.
Read Announcement- Drug:
- Cortrophin Gel
- Announced Date:
- March 3, 2025
- Indication:
- Injectable Gel
Announcement
ANI Pharmaceuticals announced U.S. Food and Drug Administration (FDA) approval of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in a prefilled syringe format.
AI Summary
ANI Pharmaceuticals has received FDA approval for its new prefilled syringe format of Purified Cortrophin® Gel (repository corticotropin injection USP). This approved presentation is available in single-dose options of 40 USP units/0.5 mL and 80 USP units/mL. The new format simplifies the treatment process by reducing the number of steps required for administration compared to the existing vial versions. According to ANI’s President and CEO, Nikhil Lalwani, this improvement is part of the company’s ongoing commitment to better meet patient needs by making treatments easier to use. The prefilled syringe is expected to be available through a specialized pharmacy network during the second quarter of 2025, reinforcing ANI Pharmaceuticals' focus on advancing its rare disease portfolio and enhancing patient care.
Read Announcement
L-Glutamine Oral Powder - FDA Regulatory Timeline and Events
L-Glutamine Oral Powder is a drug developed by ANI Pharmaceuticals for the following indication: Is the generic version of the reference listed drug (RLD) Endari®.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- L-Glutamine Oral Powder
- Announced Date:
- July 15, 2024
- Indication:
- Is the generic version of the reference listed drug (RLD) Endari®.
Announcement
ANI Pharmaceuticals, Inc. announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI's L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®.
AI Summary
ANI Pharmaceuticals, Inc. received final FDA approval for its Abbreviated New Drug Application (ANDA), and has since launched its L-Glutamine Oral Powder. This product is the generic version of the reference listed drug Endari®, making it the first AA-rated approved generic alternative. The launch highlights the strong capabilities of ANI’s research and development team and reflects the company’s focus on widening access to high-quality therapeutics for patients in need. With this approval, ANI strengthens its portfolio by providing an effective, accessible option for healthcare providers and patients managing conditions that require Endari®. The product, which has already reached approximately $20.1 million in U.S. annual sales, underscores ANI’s commitment to innovation in the generic pharmaceutical sector, ensuring that more patients benefit from advanced, affordable treatment alternatives.
Read Announcement
Naproxen - FDA Regulatory Timeline and Events
Naproxen is a drug developed by ANI Pharmaceuticals for the following indication: To treat pain, menstrual cramps, and inflammatory diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Naproxen
- Announced Date:
- July 2, 2024
- Indication:
- To treat pain, menstrual cramps, and inflammatory diseases
Announcement
ANI Pharmaceuticals, Inc. announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) and launched Naproxen Delayed-Release Tablets, USP. ANI's Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®.
AI Summary
ANI Pharmaceuticals, Inc. announced that it received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) and launched its Naproxen Delayed-Release Tablets, USP. This product is the generic version of the reference listed drug EC-Naprosyn® and offers a competitive alternative for patients. The launch marks a significant milestone for ANI as it continues to expand its portfolio with high-quality generic medications.
With the approval of this product, ANI aims to meet the needs of patients by providing an accessible and reliable option in a market with annual sales nearing $36.7 million for its branded counterpart. This step supports the company’s commitment to serving patients and improving lives, as ANI strengthens its market presence and pursues further growth through strategic product launches.
Read Announcement
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