Supplemental New Drug Application for RISPERDAL(R) CONSTA(R) Submitted to the FDA for the...

Thursday July 24, 8:30 am ET CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS - News ) today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a supplemental New Drug Application (sNDA) for RISPERDAL® CONSTA® [(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. Bipolar disorder is a brain disorder that causes unusual shifts in a person’s mood, energy and ability to function. Characterized by debilitating mood swings, from extreme highs (mania) to extreme lows (depression), bipolar I disorder affects 5.7 million, or 2.6 percent, of the American adult population in any given year.1... [read full story]