This section highlights FDA-related milestones and regulatory updates for drugs developed by Eton Pharmaceuticals (ETON).
Over the past two years, Eton Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ET-400, ET-600, and KHINDIVI™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ET-400 FDA Regulatory Events
ET-400 is a drug developed by Eton Pharmaceuticals for the following indication: Hydrocortisone Oral Solution.
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:
- ET-400
- Announced Date:
- July 15, 2024
- Estimated Event Date Range:
- February 28, 2025 - February 28, 2025
- Target Action Date:
- February 28, 2025
- Indication:
- Hydrocortisone Oral Solution
Announcement
Eton Pharmaceuticals, Inc announced that Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025.
AI Summary
Eton Pharmaceuticals, Inc recently announced a significant milestone with the U.S. Food and Drug Administration (FDA). The Company’s New Drug Application (NDA) for ET-400, a proprietary, patent-protected hydrocortisone oral solution, has been accepted by the FDA. Additionally, the NDA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025. This target date marks an important step in the potential approval process for ET-400, which is designed to treat rare diseases and is expected to be highly beneficial for children in need of this liquid formulation.
Once ET-400 gains approval, Eton anticipates capturing a larger share of the oral hydrocortisone market. The product’s patent protection extends through 2043, further supporting the company’s long-term strategy in expanding its portfolio and market presence.
Read Announcement- Drug:
- ET-400
- Announced Date:
- July 15, 2024
- Indication:
- Hydrocortisone Oral Solution
Announcement
Eton Pharmaceuticals, Inc announced the Company's New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution, has been accepted by the U.S. Food and Drug Administration (FDA)
AI Summary
Eton Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for ET-400, a new hydrocortisone oral solution formulated for children. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025, for the review process.
ET-400 is a proprietary, room temperature stable liquid formulation designed to improve treatment options in the oral hydrocortisone market. The product is backed by patent protection through 2043, ensuring a secure market position for years. Eton Pharmaceuticals believes that, along with their other product ALKINDI SPRINKLE®, ET-400 could generate significant annual sales. The company looks forward to further collaboration with the FDA as they prepare for the potential launch of ET-400 in early 2025.
Read Announcement- Drug:
- ET-400
- Announced Date:
- April 30, 2024
- Indication:
- Hydrocortisone Oral Solution
Announcement
Eton Pharmaceuticals, Inc announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of ET-400, Eton's proprietary patented formulation of hydrocortisone oral solution.
AI Summary
Eton Pharmaceuticals, Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary product, ET-400. This formulation is a patented hydrocortisone oral solution aimed at treating rare diseases in children. The company expects the FDA to complete a 10‐month review process, potentially leading to approval and a product launch in the first quarter of 2025.
ET-400 is covered by patent protection until 2043, ensuring exclusive rights to its formulation for many years. Eton is optimistic about the product’s market potential and is committed to advancing treatments that address critical health needs. The NDA submission marks an important milestone in Eton’s efforts to provide innovative therapies to patients in need.
Read Announcement- Drug:
- ET-400
- Announced Date:
- April 30, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Hydrocortisone Oral Solution
Announcement
Eton Pharmaceuticals, Inc announced that The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2025.
AI Summary
Eton Pharmaceuticals Inc. recently announced that it has submitted its New Drug Application for ET-400, a proprietary hydrocortisone oral solution. The company expects the FDA to assign this application a 10‐month review period. If everything proceeds as planned, ET-400 could receive approval and be launched in the first quarter of 2025.
This timeline is an important milestone for Eton, as it brings the company one step closer to providing a critical treatment to children in need. With ET-400 moving forward in the regulatory process and holding patent protection until 2043, the company is optimistic about its potential to address significant patient needs. The anticipated approval and launch in early 2025 mark key steps in Eton’s ongoing efforts to expand its portfolio of innovative treatments for rare diseases.
Read Announcement
ET-600 FDA Regulatory Timeline and Events
ET-600 is a drug developed by Eton Pharmaceuticals for the following indication: For the treatment of an endocrinology.
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:
- ET-600
- Announced Date:
- July 8, 2025
- Indication:
- For the treatment of an endocrinology
Announcement
Eton Pharmaceuticals, Inc announced the Company's New Drug Application (NDA) for ET-600, a proprietary patented formulation of desmopressin oral solution, has been accepted for review by the U.S. Food and Drug Administration (FDA)
AI Summary
Eton Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for ET-600, a proprietary desmopressin oral solution. The FDA has also assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026 for this review. If approved, ET-600 will be the only oral liquid option on the market, offering a safer and more accurate dosing method for pediatric patients with central diabetes insipidus (arginine vasopressin deficiency). This new formulation has strong patent protection extending through 2044, ensuring its market exclusivity. The company is preparing for the potential launch of ET-600 in early 2026, aiming to address a significant unmet need in pediatric endocrinology by offering caregivers a reliable, titratable, and approved dosage form.
Read Announcement- Drug:
- ET-600
- Announced Date:
- July 8, 2025
- Estimated Event Date Range:
- February 25, 2026 - February 25, 2026
- Target Action Date:
- February 25, 2026
- Indication:
- For the treatment of an endocrinology
Announcement
Eton Pharmaceuticals, Inc announced that NDA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026.
AI Summary
Eton Pharmaceuticals announced that its New Drug Application (NDA) for ET-600, a new formulation of desmopressin oral solution, has been accepted for review by the U.S. Food and Drug Administration. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026, for this application. This milestone brings the company one step closer to offering a treatment aimed at addressing significant dosing challenges in pediatric patients with central diabetes insipidus. ET-600, which holds patent protection until 2044, is designed to provide a reliable oral liquid option, reducing the current need for caregivers to adjust or use unapproved doses. Eton's preparation for a potential market launch in early 2026 reflects its commitment to developing innovative treatments for rare diseases.
Read Announcement- Drug:
- ET-600
- Announced Date:
- April 28, 2025
- Indication:
- For the treatment of an endocrinology
Announcement
Eton Pharmaceuticals, Inc announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-600, Eton's proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.
AI Summary
Eton Pharmaceuticals, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-600, the company’s proprietary, patented oral solution of desmopressin. ET-600 is being developed to treat central diabetes insipidus, a condition affecting thousands of pediatric patients. The NDA review is expected to take 10 months, with a potential launch of the product in the first quarter of 2026 if approved. This submission marks an important step toward providing a unique, precise oral liquid formulation to meet the specific dosing needs of children with this rare disease. Pre-launch commercial activities are already underway as the company prepares for regulatory decisions.
Read Announcement- Drug:
- ET-600
- Announced Date:
- April 28, 2025
- Estimated Event Date Range:
- January 1, 2026 - March 31, 2026
- Target Action Date:
- Q1 2026
- Indication:
- For the treatment of an endocrinology
Announcement
Eton Pharmaceuticals, Inc announced that The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2026.
AI Summary
Eton Pharmaceuticals recently submitted a New Drug Application (NDA) to the FDA for ET-600, a treatment for central diabetes insipidus. The company expects that the FDA will assign a 10-month review period to this application. This timeline could lead to a potential FDA approval and a commercial launch in the first quarter of 2026.
If approved, ET-600 would become the only FDA-approved oral liquid formulation of desmopressin, offering the small, precise doses needed for pediatric patients. Eton is already preparing for the launch, working closely with leading pediatric endocrinologists to meet the treatment needs of children affected by this condition. The company’s preparations reflect its commitment to improving treatment options for rare diseases.
Read Announcement- Drug:
- ET-600
- Announced Date:
- March 14, 2025
- Indication:
- For the treatment of an endocrinology
Announcement
Eton Pharmaceuticals, Inc announced positive results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.
AI Summary
Eton Pharmaceuticals recently announced that ET-600, its patented oral solution of desmopressin for treating central diabetes insipidus, met key bioequivalence criteria. In a study with 75 healthy adults, the drug demonstrated that it performs similarly to the FDA-approved reference product. The trial used a randomized, open-label, three-way crossover design to compare the pharmacokinetics of ET-600 with the standard treatment, showing that the experimental formulation is equivalent in delivering the active ingredient.
Based on these promising results, the company plans to submit a New Drug Application to the FDA in April 2025. If approved, ET-600 will be the only FDA-approved oral liquid formulation of desmopressin, offering a potentially more precise and titratable option, especially beneficial for pediatric patients who require careful dose adjustments.
Read Announcement- Drug:
- ET-600
- Announced Date:
- February 7, 2025
- Indication:
- For the treatment of an endocrinology
Announcement
Eton Pharmaceuticals, Inc announced that the United States Patent and Trademark Office (USPTO) has granted the Company U.S. Patent No. 12,214,010, covering its ET-600 product candidate's proprietary formulation of desmopressin oral solution.
AI Summary
Eton Pharmaceuticals announced that the USPTO granted U.S. Patent No. 12,214,010 for its ET-600 product candidate. This patent covers the company’s proprietary formulation of desmopressin oral solution, a treatment being developed for diabetes insipidus. The patent is set to expire in 2044, ensuring long-term protection for the innovative formulation.
The ET-600 formulation is specially designed to address the needs of pediatric patients who require small, precise, and titratable doses. Currently, desmopressin is only available in injectable, tablet, or nasal forms, with many children relying on less optimal compounded liquid suspensions or fractional tablet doses. Once approved by the FDA, the product is expected to be listed in the FDA Orange Book, further recognizing its importance and supporting its future market presence.
Read Announcement
KHINDIVI™ FDA Regulatory Events
KHINDIVI™ is a drug developed by Eton Pharmaceuticals for the following indication: In pediatric patients five years of age and older with adrenocortical insufficiency.
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:
- KHINDIVI™
- Announced Date:
- May 29, 2025
- Indication:
- In pediatric patients five years of age and older with adrenocortical insufficiency.
Announcement
Eton Pharmaceuticals announced that The U.S. Food and Drug Administration (FDA) approved new drug application (NDA) for Khindivi (hydrocortisone) oral solution as a replacement therapy for pediatric patients five years of age and older with adrenocortical insufficiency.
AI Summary
Eton Pharmaceuticals announced that the FDA approved its new drug application for KHINDIVI™, an innovative hydrocortisone oral solution designed as replacement therapy for pediatric patients aged five years and older with adrenocortical insufficiency. KHINDIVI is the first and only FDA-approved oral solution of hydrocortisone, formulated at 1mg/ml to allow precise dosing without the need to split or crush tablets. Its ready-to-use liquid format eliminates the need for refrigeration, mixing, or shaking, which simplifies administration for children who may have trouble swallowing tablets or require gastric tube administration. This breakthrough approval is a major step forward in managing pediatric adrenal insufficiency, offering healthcare providers a reliable and convenient treatment option that can improve dosing accuracy and help ensure better clinical outcomes for affected children.
Read Announcement- Drug:
- KHINDIVI™
- Announced Date:
- May 28, 2025
- Indication:
- In pediatric patients five years of age and older with adrenocortical insufficiency.
Announcement
Eton Pharmaceuticals, Inc announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for KHINDIVI™ (hydrocortisone) Oral Solution as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency.
AI Summary
Eton Pharmaceuticals recently received FDA approval for its New Drug Application for KHINDIVI™ (hydrocortisone) Oral Solution. This milestone product is the first and only FDA‐approved hydrocortisone liquid formulation for use as replacement therapy in pediatric patients aged five and older with adrenocortical insufficiency. Unlike tablets, KHINDIVI is a ready-to-use solution that comes in a 1mg/ml strength, eliminating the need to split or crush pills. Its design allows for simple, accurate dosing, making it especially useful for children who have difficulty swallowing or require administration via a gastric tube. This approval marks a significant advancement in pediatric care, offering a treatment option that can be tailored precisely to a child’s changing needs during a critical phase of growth and development.
Read Announcement
