U.S. health regulators on Thursday delayed approval of Teva Pharmaceutical Industries Ltd’s biotechnology medicine to boost white blood cells that is similar to Amgen Inc’s big-selling Neupogen.
The U.S. Food and Drug Administration issued a complete response letter seeking “several items” related to Teva’s drug, known as Neutroval, as a treatment for cancer patients undergoing chemotherapy, the Israel-based company said in a statement.
If the Teva drug were launched commercially in the United States, it would be the first competitor in the country for Amgen’s Neupogen, which had U.S. sales of $225 million in the second quarter. Teva has already been selling the drug, also known as XM02, under the name TevaGrastim in several European countries.
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