Drug Certification

The Food and Drug Administration, escalating its campaign against generic drugs that it believes have been marketed improperly, announced Monday that it will withdraw approval of the last remaining generic equivalent of Dyazide, a leading blood pressure drug. The FDA said it could no longer be certain that Bolar Pharmaceutical's generic drug, one of the nation's best-selling generics, is precisely equivalent to Dyazide.

The Food and Drug Administration told members of Congress on Monday that investigators gave a clean bill of health to only two of a dozen generic drug manufacturers specially targeted for investigation.

A Food and Drug Administration advisory panel Tuesday endorsed Idec Pharmaceuticals' Zevalin, putting it on track to become the first ever radioactive drug. The 15-member panel, meeting in Bethesda, Md., voted to recommend the lymphoma treatment. The action came fore federal agencies shut down in the wake of the terrorist attacks on the Pentagon and the World Trade Center. The committee endorsed Zevalin for patients with non-Hodgkin's lymphoma that defies other treatment.

The early reports tantalized: Retin-A, the highly successful acne cream, might help diminish some undesirable effects of sun-damaged skin--fine wrinkles, sagging, blotchiness. After more than three years of hype and hoopla, however, the U.S. Food and Drug Administration has put the clamp on discussion of Retin-A as a treatment for sun-damaged skin, at least for now.

A Food and Drug Administration advisory committee Thursday unanimously recommended approval of a new pill to treat adult-onset diabetes that would compete with the controversial compound Rezulin. The action by the FDA panel is a victory for Britain-based SmithKline Beecham, maker of the new pill, called Avandia. The drug still must be approved by senior FDA officials before SmithKline can market Avandia in the United States.

The Food and Drug Administration approved a new drug Monday to treat two serious AIDS-related infections, one of them a critical and often life-threatening meningitis. The drug fluconazole was approved to treat cryptococcal meningitis, an inflammation of the brain and nervous system that often strikes individuals with AIDS and can be fatal.

A new genetically engineered drug for the bleeding disorder hemophilia A was approved for marketing by the U.S. Food and Drug Administration Thursday. The drug, called factor VIII with the trade name Recombinate, is manufactured by Baxter Healthcare Corp. of Glendale. Earlier this year, FDA also approved a genetically engineered form of factor IX, which is used to treat hemophilia B. In the past, the condition was treated with a clotting factor extracted from human blood.

The government death reports provide the barest of details. Like all other adverse reaction notices filed at the Food and Drug Administration, "Individual Safety Report No. 3174412-0" provided no name or address. In this case, The Times learned the victim's identity from other documents and interviews: Her name was Rosa Delia Valenzuela. She was 63 and lived in a ranch-style house in Arcadia, at the foot of the San Gabriel Mountains.

A Food and Drug Administration panel Monday dealt a blow to loss-weary Cetus Corp. when it postponed a decision on the firm's application to market Proleukin, its costliest and most important product, to treat kidney cancer. The panel, whose recommendations are almost always accepted by the FDA, said it needed more time to review data that Cetus submitted as late as last Friday and would probably request additional meetings between Cetus officials and FDA staff.