← FDA DRUG APPROVALS

FDA NDA · NDA210868

LORBRENA

lorlatinib

Sponsor: PFIZER

APPLICATION
NDA210868
TYPE
NDA
ORIGINAL APPROVAL
2018-11-02
LATEST ACTION
2026-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LORBRENA · ReferencePrescription
LORLATINIB 25MG · TABLET · ORAL
LORBRENA · ReferencePrescription
LORLATINIB 100MG · TABLET · ORAL

Approval history

2026-01-29Labeling · Supplement 8 · standard — Letter ↗AP
2025-02-18Manufacturing (CMC) · Supplement 6 — Label ↗AP
2021-03-03Efficacy · Supplement 4 · priority — Label ↗AP
2021-02-26Labeling · Supplement 3 · standard — Label ↗AP
2021-01-22Labeling · Supplement 2 · standard — Letter ↗AP
2020-05-29Labeling · Supplement 1 · standard — Label ↗AP
2018-11-02Type 1 - New Molecular Entity · 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.

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 →