erlotinib 150 mg
1. INDICATIONS AND USAGE Erlotinib tablets are a kinase inhibitor indicated for: The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. ( 1.1 ) First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. ( 1.2 ) Limitations of Use : Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. ( 1.1 ) Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. ( 1.1 ) 1.1 Non-Small Cell Lung Cancer (NSCLC) Erlotinib tablets are indicated for: The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies (14.1 , 14.3) ]. Limitations of use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies (14.1 , 14.2) ] . Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies (14.4) ] . 1.2 Pancreatic Cancer Erlotinib tablets in combination with gemcitabine are indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5) ] .
breckenridge pharmaceutical, inc.
ROUND WHITE N150
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16. HOW SUPPLIED/STORAGE AND HANDLING 25 mg Tablets: round, biconvex, white film-coated tablets debossed with "N 25" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-890-33 100 mg Tablets: round, biconvex, white film-coated tablets debossed with "N 100" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-891-33 150 mg Tablets: round, biconvex, white film-coated tablets debossed with "N 150" on one side and plain on the other side; supplied in: Bottles of 30: NDC 51991-892-33 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
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