REMOXY® New Drug Application Accepted By The FDA With PDUFA Goal Date Of June 23, 2011
DURECT Forward-Looking Statement
The statements in this press release regarding REMOXY, its potential attributes and statements related to the expected PDUFA review date goal by the FDA, the potential of FDA approving the REMOXY NDA, the potential royalty and other payments that may be received by DURECT from REMOXY and other described products, and the potential acquisition of King by Pfizer are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the potential that the REMOXY NDA resubmission may not adequately address all of FDA's concerns, the potential that FDA may not grant regulatory approval of REMOXY, difficulties or delays in the development, testing, regulatory approval, production and commercialization of REMOXY, and unexpected adverse side-effects or inadequate therapeutic efficacy of REMOXY that could slow or prevent product approval or market acceptance, and that the Pfizer acquisition of King may not be completed. Further information regarding these and other risks is included in DURECT's Form 10-Q dated November 4, 2010 under the heading "Risk Factors."
SOURCE DURECT Corporation
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