Drug Certification

Shouldn't we be concerned about unknown, long-term side effects of RU-486? "We've had some fairly horrendous experiences with drugs that have been represented as perfectly safe, but 20 or 30 years later, we discover they're lethal. DES resulted in a significant number of vaginal cancers in daughters of women who were given the drug. The Dalkon Shield was assured to be an entirely safe product which could be used with abandon.

Amgen Inc. has asked the Food and Drug Administration to approve its Enbrel drug for patients with an inflammatory spinal disorder. Enbrel has been sold since 1998 as a treatment for rheumatoid arthritis, an inflammation of the joints, and last year won approval for psoriatic arthritis. Approval of Enbrel for ankylosing spondylitis could help the world's largest biotechnology company expand its market for the drug.

This is the season Gene Ioli used to look forward to every year, when he would dress up as Santa Claus at the UC Irvine cancer center's Christmas party. His seasonal role was a symbol of his acceptance by researchers and others at the center, where they were working on a treatment for cancerous tumors. Ioli, 44, counted himself among those who were not afraid to dream the impossible, and he built his life around work and UCI, buying a house close to the campus.

Excedrin became the first over-the-counter migraine medicine Wednesday. The Food and Drug Administration approved the extra-strength version of Excedrin as powerful enough to treat the pain of mild to moderate migraines, providing a new market for the 20-year-old painkiller. Manufacturer Bristol-Myers Squibb Co. said it would rename the product Excedrin Migraine within a few weeks, but the cost would not change. The average retail price is about $7.51 for 100 tablets.

The Food and Drug Administration on Monday approved a bold deep-brain implant that promises to ease the uncontrollable tremors experienced by thousands of patients with Parkinson's disease and an equally disabling disorder called "essential tremor." The deep-brain stimulator, which has been available in Europe for several years, has enabled many patients to once again eat, drink, write and perform an array of daily living activities by themselves, said Dr. Michael J.

The Food and Drug Administration has granted marketing approval for a liquid form of the antidepressant Prozac, the drug's maker, Eli Lilly & Co., said Thursday. Lilly called the FDA approval "another affirmation of the safety" and effectiveness of Prozac in treating clinical depression, and used its announcement to lash out at critics who have put the drug at the center of a legal and medical hornet's nest.

The Food and Drug Administration on Friday approved a new drug for so-called "Bubble Boy Disease" that will enable many children suffering from the rare genetic disorder to escape their sterile plastic environments and live relatively normal lives. Researchers said that the drug may be the forerunner of others useful for treatment of other incurable genetic disorders. "For the first time, there is a treatment for directly correcting an inherited enzyme deficiency disease," said Dr.

The Food and Drug Administration has given Genentech approval to market its genetically engineered drug Activase for use as a treatment to dissolve blood clots in lungs, the company said Wednesday. The approval comes at a propitious time for Genentech, which has traveled a rocky road with Activase, its brand name for tissue plasminogen activator (t-PA).

BioForm Medical Inc. said Wednesday that U.S. regulators approved its skin filler Radiesse to treat facial wrinkles and folds around the nose and upper lip. The Food and Drug Administration also cleared the product for facial hollowing that sometimes affects people with HIV, the virus that causes AIDS, the San Mateo, Calif.-based company said. Radiesse will compete in the market for injectable cosmetic products with Medicis Pharmaceutical Corp.'

Regulators Thursday approved the heart drug BiDil, the first medication intended for a single race. The Food and Drug Administration said its endorsement of the medicine for African Americans with heart failure was a step toward personalized medicine. The action came one week after an FDA advisory panel voted in favor of the pill after an intense debate about using race as the basis for treatment.