U.S. Regulators To Ban Chemical Tied to Strokes

Article Abstract:

Phenylpropanolamine, which is a chemical used in over-the-counter diet drugs and degongestants, will be banned by the U.S. Food and Drug Administration. The chemical is used by over 400 companies, such as SmithKline Beecham PLC, Bayer Corp. and Bristol-Myers Squibb Co.

Chemicals & Allied Products, Chemical Manufacturing, CHEMICALS AND ALLIED PRODUCTS, Chemicals, Chemical industry, Bristol-Myers Squibb Co., BMY, Bayer Corp., Phenylpropanolamine, Adrenergic alpha-agonists, Phenylpropanolamine (Medication)

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Second opinion: as drug safety concerns grow, looking overseas for solutions

Article Abstract:

The U.S. system for drug approval and the Food and Drug Administration's procedures for responding to drug safety issues after drugs are approved is discussed in light of the recent recall of several high-profile medications in the United States. Drug approval and monitoring procedures in such countries as France, Britain, and Sweden are also examined.

United Kingdom, Australia, Legal issues & crime, Product standards, safety, & recalls, Government expenditures, General services, France, Sweden, Management dynamics, Pharmaceutical preparations, Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors, Legal/Government Regulation, Metabolic Agents NEC, Product Safety-Drugs & Cosmetics, Metabolic Agents, Management, Safety and security measures, Product defects and recalls, International aspects, Government regulation, Political aspects, Powers and duties, Product safety, Company business management, Drug approval, Government finance

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SmithKline Beecham gets Lyme vaccine approval

Article Abstract:

SmithKline Beecham PLC has had its Lyme disease vaccine LYMErix approved by the US Food and Drug Administration (FDA), the first Lyme disease vaccine to gain FDA approval. Analysts, however, do not expect blockbuster sales. The disease can cause paralysis, arthritis and heart problems, and is spread by infected ticks predominantly in the Northeast and Midwest. The FDA appproved the new vaccine for people from ages 15 to 70 who live or work in grassy or wooded areas where infected ticks are present.

Biological products exc. diagnostic, Vaccines for Human Use, Vaccines

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