Teva Gains Approval for First Generic of Roche’s Xeloda

Teva Pharmaceutical Industries Ltd. (TEVA) became the first generic drugmaker to gain U.S. approval to sell a low-cost version of a Roche Holding AG (ROG) drug for colorectal and breast cancers that have spread.

Teva, based in Petach Tikva, Israel, is approved to market 150 milligram and 500 milligram strengths of capecitabine, the active ingredient in Roche’s Xeloda, the Food and Drug Administration said today in a statement. Xeloda, approved in 1998, generated $1.6 billion in sales for Basel, Switzerland-based Roche last year, according to data compiled by Bloomberg.

“This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options,’ Kathleen Uhl, acting director of the FDA’s Office of Generic Drugs, said in the statement.

Capecitabine can increase the effect of blood thinners, possibly leading to serious side effects, the FDA said.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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