Alkermes
FDA Issues Complete Response Letter for RISPERDAL® CONSTA® for Adjunctive Maintenance Treatment of Bipolar Disorder
Published in Mental Health Business Week, February 28th, 2009
Alkermes, Inc. (NASDAQ: ALKS) announced that the Food and Drug Administration (FDA) has asked Alkermes’ partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), for additional information regarding the supplemental New Drug Application (sNDA) for RISPERDAL® CONSTA® ((risperidone) Long-Acting Injection). The sNDA, submitted in April 2008, sought approval for RISPERDAL CONSTA for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently.
The Agency’s complete response outlined questions that need to be addressed prior to granting approval for the new indication, but did not...
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