MedPath

Ammtek Ltd.

Ownership
Private
Employees
-
Market Cap
-
Website

Clinical Trials

0

Active:0
Completed:0

Trial Phases

0 Phases

Drug Approvals

3

CIMA_AEMPS:2
EMA:1

Drug Approvals

Amglidia

Authorization Status
Authorised
Approval Date
May 24, 2018
EMA

Clinical Trials

No trials found

News

Eton Pharmaceuticals Acquires U.S. Rights to Amglidia for Neonatal Diabetes

• Eton Pharmaceuticals has acquired U.S. rights to Amglidia (glyburide oral suspension) from AMMTeK for treating neonatal diabetes mellitus. • Amglidia, already EMA-approved and available in Europe, addresses the unmet need for an FDA-approved oral treatment for this rare condition. • Eton plans to meet with the FDA in early 2025 and anticipates submitting an NDA for Amglidia in 2026, leveraging existing European safety and efficacy data. • The acquisition aligns with Eton's focus on pediatric endocrinology and expands its portfolio of treatments for rare diseases.

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