FDA warns Novartis over vaccine sterility
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U.S. regulators warned Novartis AG that a German plant has produced contaminated vaccines, and it has failed to track down the source of the problems, a letter released on Tuesday said.
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British health officials said Friday that US officials were warned in mid-September that ongoing problems at California-based Chiron&#39;s flu vaccine manufacturing plant in Liverpool, England, &quot;could disrupt influenza vaccine supplies to the United States
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The Food and Drug Administration failed to heed repeated warnings of contamination at Chiron&#39;s now-shuttered British flu-vaccine plant and the urging of US inspectors
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BASEL, Switzerland, August 30 /PRNewswire/ -- Novartis Pharma AG has received an &quot;approvable&quot; letter from the US Food and Drug Administration (FDA) for Certican (everolimus) in combination with Neoral (ciclosporin for microemulsion) for the prevention of
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GlaxoSmithKline Plc's rotavirus vaccine has been linked to more pneumonia-related deaths and other reactions including bronchitis, U.S. regulatory staff said in documents posted on Friday.
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The U.S. Food and Drug Administration on Wednesday ordered a strong, new warning for Pfizer Inc.'s  injectable contraceptive called Depo-Provera, saying it could permanently weaken bones.
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TORONTO - The manufacturer of an injectable contraceptive is warning teenagers and young women that the drug could permanently weaken bones.
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The U.S. Food and Drug Administration on Monday issued a warning to patients taking the painkiller naproxen after a government study showed the over-the-counter medicine can cause an increased risk of heart problems.
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Chiron Corp. is delaying shipment of  its flu vaccine, Fluvirin,  because lots containing 4 million  vaccines, do not meet product sterility standards, the  biopharmaceutical company said on Thursday .
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LONDON, Oct 6  - Doctors in Britain warned Wednesday that a decision to suspend the manufacturing license of a major flu vaccine supplier could lead to shortages of the vaccine in Britain.
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The US Food and Drug Administration announced Monday that a strong new warning will be issued for the medical-abortion drug known as RU-486, citing the risk of &quot;rare but serious complications that may occur with any abortion.
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Chiron Corp. is delaying shipment of  its flu vaccine, Fluvirin,  because lots containing 4 million  vaccines, do not meet product sterility standards, the  pharmaceutical company said on Thursday .
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The U.S. Food and Drug Administration warned GlaxoSmithKline Plc  on Thursday over misleading advertisements touting its hypertension drug called Coreg.
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The Food and Drug Administration on Tuesday warned consumers not to buy or use Actra-Rx or Yilishen because the supplements contain an ingredient that could lower blood pressure to unsafe levels.
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The Food and Drug Administration ordered a strong warning for Pfizer Inc.'s injectable contraceptive called Depo-Provera, saying it could permanently weaken bones.
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US drug regulators are warning people not to buy or consume Actra-Rx or Yilishen, a Chinese product for improving men&#39;s sexual performance, because of potential risks.
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British officials say they warned the US government last month that problems at a drug manufacturing plant could disrupt influenza vaccines to the United States.