Supplemental New Drug Application for RISPERDAL(R) CONSTA(R) Submitted to the FDA for the...
                   
tmcnet.com     Jul 24, 2008            

CAMBRIDGE, Mass. --(Business Wire)-- Alkermes, Inc. (NASDAQ: ALKS) today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), 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. 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) "RISPERDAL CONSTA, currently an... [read full story]                    


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