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J&J drug application rejected
The FDA sends company non-approval letter for long-acting schizophrenia drug Risperdal Consta.
July 1, 2002: 8:45 AM EDT

NEW YORK (CNN/Money) - Alkermes Inc. said Monday that Johnson & Johnson received a non-approval letter for its Risperdal Consta injectable schizophrenia drug application from the Food and Drug Administration.

Alkermes is a drug delivery technology company working with Johnson & Johnson on the drug. The application was for an injectable, long-acting, newer-generation antipsychotic medication, which the company said may significantly improve symptoms of schizophrenia without the need to take daily medication.

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Through a process developed by Alkermes, the drug would be injected once every two weeks.

"Johnson & Johnson is one of the world's leading health care companies. We have great confidence in relying on their ability and judgment in dealing with regulatory authorities around the world," said Richard Pops, Alkermes CEO.

Johnson & Johnson could not be reached for immediate comment.

Shares of Johnson & Johnson (JNJ: Research, Estimates) fell $2.15 to $52.26 in Friday trading.  Top of page


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Most stock quote data provided by BATS. Market indices are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer. Morningstar: © 2018 Morningstar, Inc. All Rights Reserved. Factset: FactSet Research Systems Inc. 2018. All rights reserved. Chicago Mercantile Association: Certain market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. Dow Jones: The Dow Jones branded indices are proprietary to and are calculated, distributed and marketed by DJI Opco, a subsidiary of S&P Dow Jones Indices LLC and have been licensed for use to S&P Opco, LLC and CNN. Standard & Poor's and S&P are registered trademarks of Standard & Poor's Financial Services LLC and Dow Jones is a registered trademark of Dow Jones Trademark Holdings LLC. All content of the Dow Jones branded indices © S&P Dow Jones Indices LLC 2018 and/or its affiliates.