Teva Pharmaceutical Industries Ltd. said Thursday that U.S. regulators want more information on its version of Amgen Inc.'s drug Neupogen before granting marketing approval.
Teva, the world's biggest maker of generic drugs, asked the FDA to allow it to market the generic drug under the name Neutroval. Neupogen and Neutroval are intended to treat severe neutropenia, or a lack of white blood cells, in patients being treated for cancer.
The FDA, which sent Teva a letter asking for more information, will not require any new premarket trials to gain approval, the Israeli company said.
In afternoon trading, Teva's U.S.-traded shares rose 20 cents to $52.79. Amgen shares rose 3 cents to $54.97.
**Published by AP
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