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Drug Certification

NEWS
March 19, 1999 | From Times Staff and Wire Reports
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.
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NEWS
September 17, 1999 | MARLENE CIMONS, TIMES STAFF WRITER
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.
NEWS
September 22, 1999 | MARLENE CIMONS, TIMES STAFF WRITER
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.
BUSINESS
June 30, 2001 | DENISE GELLENE, TIMES STAFF WRITER
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.
BUSINESS
July 27, 2001 | Reuters
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.
BUSINESS
June 11, 2005 | From Associated Pressvvvvvvvvv
A booster shot against whooping cough that works for adults won approval from the Food and Drug Administration. Sanofi-Aventis' Adacel is for people ages 11 to 64. A month ago, the FDA OKd the first-ever whooping cough booster, GlaxoSmithKline's Boostrix, which is for 10- to 18-year-olds. The cough, so strong it can result in broken ribs, was once thought to be history thanks to effective vaccination of babies and toddlers.
BUSINESS
December 2, 2005 | From Bloomberg News
Chiron Corp. and Gen-Probe Inc. have won the first U.S. approval of a test to screen donated blood for the deadly West Nile virus typically transmitted to humans by mosquito bites. Blood banks in the United States have been using experimental tests, including Chiron and Gen-Probe's Procleix, to screen for the virus, the Food and Drug Administration said Thursday in a statement. The tests have identified the virus in about 1,600 donations, which were then destroyed, the FDA said.
BUSINESS
January 1, 2005 | From Associated Press
Pfizer Inc. said the Food and Drug Administration had approved its medication for pain caused by nerve damage from diabetes or shingles, but it is still under review for treating partial seizures in adults. Pfizer said that Lyrica was the first FDA-approved treatment for this pain, often described as burning, tingling, sharp or stabbing or as pins and needles in the feet, legs, hands or arms.
BUSINESS
September 7, 2005 | From Reuters
A new vaccine that combines four childhood immunizations has won approval from the U.S. Food and Drug Administration, Merck & Co. said Tuesday. The vaccine, called Proquad, is approved to protect children 12 months to 12 years of age against measles, mumps, rubella and chickenpox.
BUSINESS
September 1, 2005 | Denise Gellene, Times Staff Writer
The supply outlook for flu vaccine this year improved Wednesday as two manufacturers cleared crucial regulatory hurdles. Chiron Corp.'s troubled factory in England passed a key Food and Drug Administration inspection, putting the company on track to return to the U.S. market. British pharmaceutical giant GlaxoSmithKline, meanwhile, received FDA approval to sell its flu shots in the U.S. for the first time. Taken together, the developments eased worries about a severe vaccine shortage.
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