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news.Johnson & Johnson Pharmaceutical R&D, a wholly-owned subsidiary of Johnson & Johnson, has received the FDA complete response letter for Risperdal Consta for the adjunctive maintenance treatment of bipolar disorder.
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The FDA has asked for additional information regarding the company’s supplemental new drug application (sNDA) for Risperdal Consta 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 request additional studies.
Johnson & Johnson Pharmaceutical R&D (J&JPRD) is currently evaluating the FDA’s complete response letter and will work with the agency to resolve any outstanding questions.
Risperdal Consta is marketed in the US by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals and manufactured by Alkermes.