FDA panel backs Searle arthritis drug but suggests warnings about side effects

Article Abstract:

Monsanto's Searle & Co. drug unit will market its Cox-2 inhibitor for arthritis pain, but must include warnings about side effects, more warnings than the company had wanted. Even though the company performed its clinical trials on 15,000 people, many more than is typical or required, a federal advisory panel wants the company to warn about gastrointestinal problems. Every year between 10,000 and 20,000 people die from the use of painkillers according to the FDA.

Marketing procedures, New Products/Services, Legal/Government Regulation, Medicinal and Botanical Manufacturing, Medicinals and botanicals, Bulk Analgesics & Antipyretics, Marketing, Investigations, Complications and side effects, Drug therapy, Monsanto Co., MTC, Arthritis, Analgesics, Anti-inflammatory drugs, Anti-inflammatory agents, G.D. Searle and Co., Bulk drugs, Nervous system agents

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Glaxo Wellcome's new flu drug fails to clear FDA panel on trial results

Article Abstract:

A preliminary decision from an FDA advisory panel is to not approve flu drug Relenza submitted by Britain's Glaxo Wellcome. The drug, that is supposed to shorten flu symptoms, showed conflicting clinical trial data. The company was disappointed in the results after finding much better results in the European trials.

Comment:

Flu drug clinical trials were a disappointment

United Kingdom, Foreign operations, Product information, Pharmaceutical Preparation Manufacturing, Pharmaceutical preparations, Nongeneric Drugs, Care and treatment, Research, Evaluation, Drugs, Testing, Clinical trials, Influenza, Glaxo Wellcome PLC

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