Johnson & Johnson
said on Monday that the Food and Drug Administration rejected its application for a long-lasting, injectable version of the schizophrenia drug Risperdal Consta.
The company received a nonapprovable letter from the agency, but, according to Johnson & Johnson, the letter "invited further dialogue with the agency to resolve questions regarding certain aspects of the pre-clinical data."
J&J added that no significant concerns were raised about the manufacturing process, so the company feels it can resolve the FDA's questions.
Risperdal Consta was developed using the extended-release drug delivery technology created by
. If the drug were to be approved by the FDA, Alkermes would manufacture it, while
Janssen Pharmaceutical Products
, a wholly owned subsidiary of Johnson & Johnson, would market it in the U.S.
Shares of J&J were recently trading down about 2% to $51.25 in Instinet premarket trading, while Alkermes was plunging about 50% to $8.20.