eribulin mesylate
eribulin mesylate is listed in the FDA National Drug Code directory with 13 NDC codes, marketed under brand names including ERIBULIN MESYLATE, Eribulin Mesylate, eribulin mesylate. Available dosage forms: injection, powder.
Drug Details
- Generic Name
- eribulin mesylate
- Brand Names
- ERIBULIN MESYLATE, Eribulin Mesylate, eribulin mesylate, Halaven
- Application Number
- ANDA218142
- Sponsor
- GLENMARK PHARMACEUTICALS INC., USA
- NDC Codes
- 13
- Dosage Forms
- INJECTION, POWDER
- Routes
- INTRAVENOUS
- Active Ingredients
- ERIBULIN MESYLATE
Indications and Usage
1 INDICATIONS AND USAGE Eribulin mesylate injection is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. ( 1.2 ) 1.1 Metastatic Breast Cancer Eribulin mesylate injection is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting [see Clinical Studies (14.1) ] . 1.2 Liposarcoma Eribulin mesylate injection is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen [see Clinical Studies (14.2) ] .