Roche ceases Accutane sales.(NEWS FROM THE FDA)(Brief article)

Citing a significant loss of market share, Roche announced that it will cease manufacturing the retinoid Accutane, but dermatologists say that the company's pullout will not affect patients' access to the drug and will not affect the risk management program known as iPledge.

In a statement, Roche noted that generic competitors now own the market for prescription isotretinoin. Accutane has less than a 5% share for the acne therapy, said the company. In its latest year-end financial statement, Roche did not specify sales for Accutane, but it was not among the top 20 best sellers.

The company "has been faced with high costs from personal injury lawsuits that the company continues to defend vigorously," according to Roche. Accutane was first marketed in 1982; the initial round of suits mostly alleged the drug was associated with a potential for depression and suicide. More recently, at least 500 suits have been filed alleging that Accutane causes irritable bowel disease.

The generic companies aren't likely to dodge future litigation, but a spokesperson for one of the generic manufacturers, Barr Laboratories Inc., said that Barr intended to continue making and distributing isotretinoin.

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