January 29, 2007 |
New birth control pills that are less effective than the original contraceptives of the 1960s in preventing pregnancy could win federal approval if they promise other benefits, under a recommendation by health advisors. Food and Drug Administration advisors refused last week to recommend a set standard on how often next-generation pills would have to fail for them to be denied federal approval. "We don't want an arbitrary number to be ascribed," said Dr.
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.
November 22, 2003 |
A Food and Drug Administration advisory panel Friday endorsed competing injectable gels that combat facial wrinkles, smoothing the way for a big marketing showdown. The panel recommended that the FDA approve Restylane by Medicis Pharmaceutical Corp. and Hylaform by Inamed Corp., collagen alternatives already available in Europe, Canada and Mexico. The FDA typically follows its experts' advice.
August 31, 1999 |
Lake Forest-based I-Flow Corp. said Monday it received approval from the Food and Drug Administration to market a kit that helps control pain by delivering local anesthesia near a nerve. The company's stock closed at $3.91, up 9 cents a share.
December 14, 1999
Allergan Inc. said Monday that the U.S. Food and Drug Administration has approved the marketing of the company's Alocril solution for the treatment of itch associated with allergic conjunctivitis. Allergan expects to launch the product by March. "The approval of Alocril provides an important new option for the treatment of a common ocular disorder," said Dr. Lester J. Kaplan, who heads the Irvine eye care company's research and development.
March 19, 1999 |
The manufacturer of the diabetes pill Rezulin now believes that the drug has been linked to the deaths of as many as 35 patients, company representatives said Thursday. "To the best of our knowledge, the number is between 33 and 35 patients," said Stephen J. Mock, a spokesman and vice president of New Jersey-based Warner-Lambert Co. That figure would be an increase from the 26 Rezulin-related deaths that Warner-Lambert acknowledged in a Dec. 31 filing with the Food and Drug Administration.
September 17, 1999 |
The Food and Drug Administration on Thursday approved a new breast cancer drug for people whose disease has spread to the lymph nodes. The drug, when used after surgery with two other standard drugs, appears to significantly improve survival over another common regimen. But it also carries the risk of more side effects than the other treatments, a factor that raises the inevitable difficult choices patients and their physicians face in making breast cancer treatment decisions.
September 22, 1999 |
The Food and Drug Administration, mindful of the growing public health threat of drug-resistant bacteria, on Tuesday approved the first alternative in three decades to the one antibiotic that works when standard drugs do not. The new drug, Synercid, is the first approved to treat infections that fail to respond to vancomycin, making it an important weapon in the war against infections. Health officials estimated that there are as many as 20,000 cases of these resistant infections annually.
June 30, 2001 |
Amgen Inc. said Friday that it won't receive government approval of its second-generation anemia treatment by the end of this month, as it had expected. The Thousand Oaks-based biotechnology company had forecast Food and Drug Administration clearance for Aranesp during the first half of 2001. Amgen, the world's largest biotechnology company, said discussions about what to put on the label are continuing with the FDA and are encouraging.
July 27, 2001 |
Schering-Plough Corp. said the Food and Drug Administration agreed to allow it to sell its already marketed hepatitis C drug, Rebetol, as an individual treatment--a decision long-awaited by patients seeking a more effective way to use the medicine. The ruling allows Schering-Plough to market separate packages of Costa Mesa-based ICN Pharmaceuticals Inc.'s Rebetol capsules, which are available only in a combination package with an injectable interferon drug called Intron-A.