FDA Lets SuperGen Make Leukemia Drug

SuperGen Inc. said it won approval from the Food and Drug Administration to make in the U.S. a drug for treating a rare form of leukemia. When SuperGen had bought the drug, Nipent, from Warner-Lambert Co., in September 1996, it inherited the right to sell it but needed FDA approval for its manufacture. Nipent, known chemically as pentostatin, is used to treat hairy-cell leukemia, a rare blood disease that strikes mostly men, causes severe anemia and enlarges the spleen. SuperGen, based in San Ramon, Calif., said in October that a study found 209 out of 241 patients with hairy-cell leukemia survived after being treated with Nipent for up to a year. The company said it is studying other possible uses for the drug. SuperGen develops drugs to treat cancer, blood cell disorders, diabetes and obesity.