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Amgen Asks FDA to Approve Biotech Drug

November 10, 1987

Amgen is seeking federal approval to sell its anti-anemia drug erythropoietin, or EPO.

The Thousand Oaks biotechnology company last week filed a product license application with the Food and Drug Administration to sell EPO, a hormone that controls the production of red blood cells and is considered an advancement in the treatment for dialysis patients who need frequent blood transfusions.

Analysts have said Amgen could receive approval to sell the drug by late 1988. The potential market for EPO in the United States has been estimated at $300 million.

Amgen said it plans to sell the drug in the United States through its own sales organization and to the rest of the world through partners Johnson & Johnson and Kirin Brewery of Japan.

Last month, Amgen received a patent for its biotechnology process for making EPO and filed two patent infringement lawsuits against rivals that are developing a more naturally occurring form of EPO. Amgen was countersued for patent infringement by Genetics Institute of Cambridge, Mass., and its partner, Chugai Pharmaceutical of Japan.

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