lorlatinib

FDA Drug Profile — Lorbrena

lorlatinib is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand name including Lorbrena. Available dosage form: tablet, film coated.

Drug Details

Generic Name
lorlatinib
Brand Names
Lorbrena
Application Number
NDA210868
Sponsor
U.S. Pharmaceuticals
NDC Codes
5
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
LORLATINIB

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 )