recorlev

Generic: levoketoconazole

recorlev: developed by 1 company · 1 FDA decision. Updated within the last hour.

Development Pipeline (1)

FDA Decisions

Approval1 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(SBBP)

Frequently asked questions

Who is developing recorlev?

recorlev is being developed by Strongbridge Biopharma plc.

What is recorlev's latest FDA decision?

The most recent tracked FDA decision for recorlev is Approval for 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, dated December 30, 2021.

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    recorlev — Drug Pipeline, Trials & FDA Status | BioSniper