Generic Accutane faces potential delays

Drug Store News, March 25, 2002 by James Frederick

Hoffman-LaRoche president and chief executive officer George Abercrombie has reiterated concerns that generic copies of the company's anti-acne drug Accutane (isotretinoin) could make finding pregnant patients a problem.

"We've filed a citizen's petition with the Food and Drug Administration to develop and coordinate a pregnancy risk management system in a multi-source environment," Abercrombie said at a February news conference in New York.

The last Accutane patent expired in February. As of early this month, no generic drug manufacturer had sought FDA approval to market a generic version of the drug, according to the FDA Web site.

Before losing patent protection, Roche instituted a strict pregnancy test requirement to prevent pregnant women from taking Accutane, which can cause birth defects. Roche's move is viewed by some as an attempt to retain the last of Accutane's profits by delaying generic entries. Global Accutane sales reached $675 million in 2001.