Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.

About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

In April, Basel, Switzerland-based Roche announced first- quarter sales rose 7 percent to 11.6 billion Swiss francs ($10.1 billion) from 10.9 billion francs a year earlier. Roche completed its $46.8 billion purchase of partner Genentech Inc. in March, gaining access to cancer drugs such as Avastin and Rituxan.

5,000 Cases

The company faces as many as 5,000 personal-injury claims over Accutane, said Michael Hook, a Pensacola, Florida-based attorney. He won a $10.5 million verdict against the drugmaker over the medicine in April 2008. He noted that Roche has lost six cases that have gone to trial over the drug.

Original Article

Accutane Recalled is a post from: Accutane Recall | Accutane Lawsuit