← FDA DRUG APPROVALS

FDA NDA · NDA215400

BREKIYA

dihydroergotamine mesylate

Sponsor: AMNEAL

APPLICATION
NDA215400
TYPE
NDA
ORIGINAL APPROVAL
2025-05-14
LATEST ACTION
2025-05-14
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BREKIYA (AUTOINJECTOR) · ReferencePrescription
DIHYDROERGOTAMINE MESYLATE 1MG/ML · SOLUTION · SUBCUTANEOUS

Approval history

2025-05-14Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →