melphalan hydrochloride injection, powder, lyophilized, for solution
Drug Details
- Generic Name
- melphalan hydrochloride injection, powder, lyophilized, for solution
- Brand Names
- Hepzato Kit
- Application Number
- NDA201848
- Sponsor
- Delcath Systems, Inc.
- NDC Codes
- 1
- Dosage Forms
- KIT
- Routes
- INTRA-ARTERIAL
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE HEPZATO for injection, as a component of the HEPZATO KIT, is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. HEPZATO is an alkylating drug indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.( 1 )