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.
February 27, 2004 |
Genentech Inc. on Thursday won Food and Drug Administration approval of its colon cancer drug Avastin, the first medication to shrink tumors by choking the blood vessels that feed them. Industry analysts said the drug could become a $2-billion-a-year product, which would make it the best-selling cancer medication to date. Wall Street drove Genentech's shares up 7%, adding $3.8 billion to the total market value of the South San Francisco company.
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.
February 13, 1996 |
Balding Americans, take note: The federal government has just made it a little easier to wage war on Mother Nature. Eight years after approving the first and only known medical treatment for hereditary baldness, the FDA took that action one step further Monday, making Rogaine an over-the-counter drug as easy to obtain from a pharmacy as aspirin. The move, which reverses an earlier FDA decision, prompted the drug's manufacturer, Michigan-based Pharmacia & Upjohn Inc.
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.
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.
August 25, 1998 |
Monsanto Co. said its much-anticipated painkiller, one of a new class of drugs with multibillion-dollar sales potential for conditions such as arthritis, will get a faster-than-usual review by the Food and Drug Administration. The priority review designation generally means that the FDA will decide whether to approve the drug within six months instead of a year. Monsanto, which expects to complete a merger with American Home Products Corp.