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.
CALIFORNIA | LOCAL
September 16, 1998 |
The president of a Whittier Research Company was sentenced to 15 months in federal prison Tuesday for falsifying results of human drug tests submitted to the Food and Drug Administration. Dr. Robert A. Fiddes, 53, of Palos Verdes, pleaded guilty to a charge of making false statements to the FDA about drugs being considered for approval. Two employees at Fiddes' Southern California Research Institute are scheduled to be sentenced on similar charges today by U.S. District Judge Robert M. Takasugi.
March 23, 2006 |
Two companies that make a controversial multiple sclerosis drug said Wednesday that U.S. regulators had delayed for 90 days a decision on whether to permit it back on the market. Biogen Idec Inc. of Cambridge, Mass., and Elan Corp. of Dublin, Ireland, said in a joint statement that the Food and Drug Administration had postponed until June 28 a decision on whether to re-approve the drug, called Tysabri. Biogen Idec fell 21 cents to $48.10 on the news.
March 9, 2006 |
An advisory panel on Wednesday unanimously recommended that the Food and Drug Administration allow an effective but risky multiple sclerosis drug back on the market. The committee proposed restrictions on the use of the drug, called Tysabri, and the creation of an elaborate system to monitor patients for signs of a rare brain infection that can occur as a side effect. The panel's recommendation, which is expected to be adopted by the agency, was good news for Tysabri's makers, Biogen Idec Inc.
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.