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Roche Discontinues and Plans to Delist Accutane in the US.


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#1 Wynne


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Posted 27 July 2009 - 09:00 PM

Link to Roche's news:
Copy/paste of Roche' news release:
June 29, 2009 -- Nutley, N.J.

Roche Discontinues and Plans to Delist Accutane in the U.S.

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 complete Accutane prescribing information at www.rocheusa.com/products/accutane and www.iPledgeProgram.com.

Generics are NOT affected by Roche's decision. Generic isotretinoin is still available in the US and abroad.

Take responsibility for your health; read the full prescribing information for any medication you take and understand that not all risks or potential side effects will likely ever be fully known.

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