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Risperdal Consta sNDA Submitted

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a Supplemental New Drug Application (sNDA) for Risperdal Consta  to the FDA seeking approval for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with frequently relapsing bipolar disorder (FRBD). FRBD is defined as four or more manic or depressive episodes in the previous year that require a doctor’s care. The condition may affect 10-20% of the 27 million...

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