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Hoffmann-La Roche Inc. has notified the U.S. Food and Drug Administration of its intent to immediately discontinue the manufacture and distribution of Accutane, its ground-breaking treatment for severe recalcitrant nodular acne that has not responded to other therapies. This decision is being taken for business reasons during a reevaluation of our product portfolio of medicines that are now available from generic manufacturers, and is not being taken for reasons of safety or efficacy.

Today in Regulatory Issues...keeping you current

Watson Files FDA Application for Generic Rozerem
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Bristol-Myers Squibb And Pfizer Announce Plans To Submit Regulatory Filing For Apixaban In Europe
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Non-safety-related voluntary recall of a limited portion of Daytrana (methylphenidate transdermal system) patches announced
Shire, 12/07/09