December 22, 1990 |
Trapped in the cross-fire between scientists, drug companies and certain AIDS activists, Dr. Ellen Cooper, the U.S. Food and Drug Administration's top AIDS drug regulator, has requested a transfer to a less-pressured post within the agency. Cooper refused to comment on the move Friday, but friends, associates and an FDA spokesman confirmed her decision to step down. Many said her departure from her post as director of the FDA's Division of Anti-Viral Drug Products in Bethesda, Md.
December 29, 1997 |
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.
September 15, 1989 |
A former generic drug company executive was fined $250,000 and ordered to serve 60 days of an 18-month jail sentence after pleading guilty to bribing Food and Drug Administration officials, the U.S. attorney in Baltimore announced Thursday. Dilip P. Shah, 43, a founder and former president of Quad Pharmaceuticals Inc., also was ordered to devote 12 months of full-time community service to the American Cancer Society.
July 29, 1995 |
A Food and Drug Administration advisory panel declined Friday to recommend approval--or disapproval--of a cheaper, generic version of the nation's most prescribed drug, saying it doesn't have enough information. The committee concluded there was "insufficient data" to determine if a generic estrogen drug had to contain all of the components that are in the top-selling Premarin, a hormone-replacement drug used by about 9 million post-menopausal women.
January 12, 1994 |
The Food and Drug Administration has approved a popular prescription arthritis drug for marketing as an over-the-counter pain reliever--a move that will cause competitive headaches for the makers of Advil, Tylenol and other pain remedies. The drug, naproxen sodium, is the first non-prescription pain reliever to win FDA approval since ibuprofen a decade ago.
April 20, 2005 |
Canada became the first nation Tuesday to approve a pharmaceutical prescription spray derived from the cannabis plant, a move that could shift the medical marijuana debate in the U.S. The drug, called Sativex, is being produced by GW Pharmaceuticals of Britain and is expected to be available in Canadian pharmacies within weeks, principally for the treatment of pain from multiple sclerosis.
March 24, 2004 |
The Food and Drug Administration approved the first generic versions of the controversial painkiller Oxycontin late Tuesday, a move that promises to significantly lower the drug's cost. Oxycontin is a long-lasting version of oxycodone, a narcotic considered important therapy for many patients suffering long-term, severe pain from cancer or other illnesses. When swallowed whole, the tablet provides 12 hours of pain relief.
October 4, 2001 |
Sufferers of Crohn's disease won a new treatment that promises to decrease the intestinal inflammation that causes much of the disorder's misery. The Food and Drug Administration approved Entocort EC, saying the capsule promises fewer side effects than other steroids, such as prednisone, that are used to treat Crohn's. Entocort EC capsules release the medication, known chemically as budesonide, once they reach the intestine.
September 11, 1989 |
Two generic drug companies already immersed in bribery charges have more pervasive problems than originally thought, and the companies likely will be investigated by the Justice Department's criminal division, two key members of Congress say in documents to be made public today. An admitted bribery payment to Food and Drug Administration employees "appears to be only the tip of the iceberg in a story . . . rife with problems," according to statements by Reps. John D. Dingell (D-Mich.
September 28, 1991 |
The Food and Drug Administration on Friday approved a new drug to treat a serious AIDS-related infection that often results in blindness. The drug, foscarnet, was approved to treat cytomegalovirus retinitis, an eye infection that can cause blindness in people with weakened immune systems. CMV retinitis afflicts an estimated 46% of AIDS patients who have reached the latter stages of the disease, the FDA said. It is the second drug to be approved for the condition.