FDA gets a cautious recommendation to approve vaccine for Lyme disease

Article Abstract:

The government received a recommendation from a federal advisory board to approve the first Lyme disease vaccine. Lyme disease affects thousands of people annually. SmithKline Beecham PLC's LYMErix could be used to protect people, between the ages of 15 and 70, against Lyme disease. The advisory panel determined that the vaccine does satisfy the Food and Drug Administration's (FDA) requirements, but that the vaccine should continued to be tested for safety.

Comment:

Government receives recommendation from a federal advisory board to approve company's Lyme disease vaccine

Vaccines for Human Use, SmithKline Beecham PLC, Vaccines

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FDA expected to approve new drug from CollaGenex to fight gum disease

Article Abstract:

CollaGenex Pharmaceuticals Inc.'s Periostat drug is expected to win the approval of the Food and Drug Administration (FDA) during the second week of October 1998. Periostat is a low-dose version of doxycycline, which is designed to fight periodontal disease. The drug can lessen the need for continuous bacterial cleaning treatments at the hands of dentists. Periostat can also stop periodontal disease from spreading.

Comment:

Periostat drug expected to win approval of the Food and Drug Administration (FDA) during the second week of October 1998

Dental Analgesics, CollaGenex Pharmaceuticals Inc.

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FDA rules dietary supplement dupes cholesterol drug, raising legal issues

Article Abstract:

The Food and Drug Administration (FDA) announced that a popular dietary supplement, called Cholestin, is an unapproved treatment. The drug, made by Pharmanex Inc., is said to lower cholesterol levels. The FDA's ruling amounts to the prohibition of the sale of Cholestin. The FDA and the pharmaceutical industry are struggling to define cases where dietary supplements are in reality, medications.

Comment:

FDA announces that a popular dietary supplement, called Cholestin, is an unapproved treatment

Lipotropics & Cholesterol Reducers, Pharmanex Inc.

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