Levoketoconazole
Drug Details
- Generic Name
- Levoketoconazole
- Brand Names
- Recorlev
- Application Number
- NDA214133
- Sponsor
- Piramal Pharma Limited
- NDC Codes
- 3
- Dosage Forms
- POWDER, TABLET
- Routes
- ORAL
- Active Ingredients
- LEVOKETOCONAZOLE
Indications and Usage
1 INDICATIONS AND USAGE RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of Use RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established. RECORLEV is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative ( 1 ) Limitations of Use RECORLEV is not approved for the treatment of fungal infections ( 1 )