← FDA DRUG APPROVALS

FDA NDA · NDA211358

ORKAMBI

lumacaftor and ivacaftor

Sponsor: VERTEX PHARMS INC

APPLICATION
NDA211358
TYPE
NDA
ORIGINAL APPROVAL
2018-08-07
LATEST ACTION
2026-03-17
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

ORKAMBI · ReferencePrescription
IVACAFTOR 188MG/PACKET, LUMACAFTOR 150MG/PACKET · GRANULE · ORAL
ORKAMBI · ReferencePrescription
IVACAFTOR 94MG/PACKET, LUMACAFTOR 75MG/PACKET · GRANULE · ORAL
ORKAMBI · ReferencePrescription
IVACAFTOR 125MG/PACKET, LUMACAFTOR 100MG/PACKET · GRANULE · ORAL

Approval history

2026-03-17Labeling · Supplement 8 · standard — Letter ↗AP
2025-09-25Labeling · Supplement 7 · standard — Letter ↗AP
2024-12-13Efficacy · Supplement 6 · priority — Label ↗AP
2023-08-03Labeling · Supplement 5 · standard — Letter ↗AP
2022-09-02Efficacy · Supplement 4 · priority — Letter ↗AP
2018-08-07Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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