LORBRENA
NDA 210868 · New Drug Application (NDA) Prescription
LORLATINIB
- Sponsor (Drugs@FDA)
- PFIZER Company: PFIZER INC (PFE)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | LORBRENA LORLATINIB | TABLET;ORAL 25MG | Prescription | – | Reference listed drug | RXApproved |
| 002 | LORBRENA LORLATINIB | TABLET;ORAL 100MG | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 8 | Approved | standard | Labeling | Letter for Supplement 8 (opens in a new tab)Label for Supplement 8 (opens in a new tab) | |
| Supplement 6 | Approved | n/a | Manufacturing (CMC) | Letter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab) | |
| Supplement 4 | Approved | priority | Efficacy | Letter for Supplement 4 (opens in a new tab)Label for Supplement 4 (opens in a new tab) | |
| Supplement 3 | Approved | standard | Labeling | Letter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab) | |
| Supplement 2 | Approved | standard | Labeling | Letter for Supplement 2 (opens in a new tab)Label for Supplement 2 (opens in a new tab) | |
| Supplement 1 | Approved | standard | Labeling | Letter for Supplement 1 (opens in a new tab)Label for Supplement 1 (opens in a new tab) | |
| Original 1 | Approved | priority | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
10 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 8680111Product 001 | Drug substance, Drug product | – | ||
| 10420749Product 001 | Drug substance, Drug product | U-2633 | ||
| 10420749Product 001 | Drug substance, Drug product | U-3096 | ||
| 11020376Product 001 | Drug product | – | ||
| 11299500Product 001 | Drug substance | – | ||
| 8680111Product 002 | Drug substance, Drug product | – | ||
| 10420749Product 002 | Drug substance, Drug product | U-2633 | ||
| 10420749Product 002 | Drug substance, Drug product | U-3096 | ||
| 11020376Product 002 | Drug product | – | ||
| 11299500Product 002 | Drug substance | – |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| ODE-349 | 001 | |
| ODE-349 | 002 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
Lorbrena
LORLATINIB · Pfizer Laboratories Div Pfizer Inc · ORAL · Version 13 · effective
Indications and usage
1 INDICATIONS AND USAGE LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )
Lorbrena
LORLATINIB · U.S. Pharmaceuticals · ORAL · Version 3 · effective
Indications and usage
1 INDICATIONS AND USAGE LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )
NDC products
3 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0069-0227 in openFDA (opens in a new tab) | Lorbrena lorlatinib | Pfizer Laboratories Div Pfizer Inc | TABLET, FILM COATED ORAL | NDA | From |
| 0069-0231 in openFDA (opens in a new tab) | Lorbrena lorlatinib | Pfizer Laboratories Div Pfizer Inc | TABLET, FILM COATED ORAL | NDA | From |
| 63539-927 in openFDA (opens in a new tab) | Lorbrena lorlatinib | U.S. Pharmaceuticals | TABLET, FILM COATED ORAL | NDA | From |
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.