Thursday, July 24, 2008

Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Bipolar Disorder

July 24, 2008--Alkermes, Inc. today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., submitted a supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R) ((risperidone) Long-Acting Injection) to the U.S. Food and Drug Administration (FDA) for approval as monotherapy in the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adults.

The details can be read here.

No comments: