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| June 29, 2009 -- Nutley, N.J. | |
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Roche Discontinues and Plans to Delist Accutane in the U.S. |
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Hoffmann-La Roche Inc. has notified the U.S. Food and Drug
Administration (FDA) of its intent to immediately
discontinue the manufacture and distribution of
Accutane® (isotretinoin), 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.
Since 2002, generic formulations of isotretinoin, the active ingredient in Accutane, entered the market. Current manufacturers/distributors are Barr Laboratories Inc., Genpharm, Inc. / Mylan Pharmaceuticals Inc., and Ranbaxy Laboratories Inc. As a result, Roche's prescription market share of Accutane has steadily declined for several years and is now below 5 percent. Therefore, the generic companies can supply the market. In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously. Roche stands behind the safety of Accutane and the rigorous risk management program Roche developed over decades of cooperation with the FDA and the American Academy of Dermatology. Currently, the iPledge pregnancy risk management program is a model in the pharmaceutical industry. Roche is committed to working with the FDA and the isotretinoin generic manufacturers for the eventual transition of Roche's business responsibilities in iPledge to the remaining sponsors. We are proud of Accutane, a product of original Roche research that has been used in the treatment of severe recalcitrant nodular acne by more than 13 million patients since it was introduced in 1982. Please see Accutane full prescribing information and learn more about the iPledge program. |
View Material Safety Data Sheet (MSDS) for information on handling Accutane in a workplace such as a pharmacy or a hospital.