FDA Approves Teva/MedinCell's Antipsychotic Injection For Adult Schizophrenia Patients

The FDA has approved Teva Pharmaceuticals Industries Ltd TEVA and MedinCell's approved Uzedy (risperidone) extended-release injectable suspension for schizophrenia in adults.
Uzedy is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone.
Therapeutic blood concentrations are reached within 6-24 hours of a single dose.
Also Read: Stage Set For Generics As Biden Admin Asks Supreme Court To Hear Skinny Labels Case Between GSK, Teva.
The use of novel SteadyTeq technology in UZEDY controls the release of risperidone over time. The initiation of treatment requires no loading dose or oral supplementation. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.
The Wholesale Acquisition Cost for Uzedy ranges from $1,232 to $3,080 monthly, depending on dosage strength, and will be available in the U.S. in the coming weeks.
Price Action: TEVA shares are up 0.92% at $8.81 premarket on the last check Monday.