FDA wants more data on J&J and Alkermes' Risperdal Consta
The Food and Drug Administration has asked the USA's Alkermes and partner Johnson & Johnson for additional information regarding their supplemental New Drug Application for Risperdal Consta (risperidone). The sNDA, submitted in April 2008, sought approval for the drug as adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently. The firms stress that the agency's response did not request additional studies and they will work with the FDA to resolve any outstanding questions. Risperdal Consta was initially approved in the USA in 2003.
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