Additional injection site approved for Risperdal Consta
Date Posted: October 10, 2008
The FDA has approved the injection of Risperdal Consta (risperidone long-acting injection, from
Janssen)
into the deltoid muscle of the arm for the treatment of schizophrenia. This approval was based on
clinical studies demonstrating similar safety, tolerability, and bioequivalence of deltoid and gluteal injections.
Risperdal Consta was previously approved for gluteal injection only.
Risperdal Consta
dose packs containing two separate, non-interchangeable needles for either gluteal or deltoid injection will
be available by the end of 2008.