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ANI Pharmaceuticals (ANIP) FDA Events

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FDA Events for ANI Pharmaceuticals (ANIP)

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.

ANI Pharmaceuticals' Drugs in FDA Review

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.

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.

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.

ANI Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, ANI Pharmaceuticals (ANIP) has reported FDA regulatory activity for the following drugs: Cortrophin Gel, L-Glutamine Oral Powder and Naproxen.

The most recent FDA-related event for ANI Pharmaceuticals occurred on June 12, 2025, involving Cortrophin Gel. The update was categorized as "Preclinical Data," with the company reporting: "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."

Current therapies from ANI Pharmaceuticals in review with the FDA target conditions such as:

  • Injectable Gel - Cortrophin Gel
  • Is the generic version of the reference listed drug (RLD) Endari®. - L-Glutamine Oral Powder
  • To treat pain, menstrual cramps, and inflammatory diseases - Naproxen

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ANIP) was last updated on 7/10/2025 by MarketBeat.com Staff
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