← FDA DRUG APPROVALS
FDA BLA · BLA761412
LANGLARA
insulin glargine-aldy
Sponsor: SUNSHINE LAKE PHARMA CO LTD
APPLICATION
BLA761412
TYPE
BLA
ORIGINAL APPROVAL
2026-04-29
LATEST ACTION
2026-04-29
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LANGLARAPrescription
INSULIN GLARGINE-ALDY 100UNITS/ML · INJECTABLE · SUBCUTANEOUS
Approval history
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.