FDA asks court to limit scope of ruling on off-label drug info; WLF finds no basis for action

Article Abstract:

The Washington Legal Foundation (WLF) contends that the US District Court in Washington, DC, has rightfully set limitations on the Food and Drug Administration's (FDA) ability by restricting scientific information dissemination to the medical profession. The FDA had earlier appealed that the court injunction only be applied to the three guidance documents cited in the case. The agency is expected to maintain its position that free flow of educational information about off-label uses of drugs counters its ability to perform its legally authorized functions of approving drugs.

Government domestic functions, Regulation of Agricultural Marketing and Commodities, Food & Drug Administration

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Generic albuterol is equivalent to Proventil

Article Abstract:

Schering-Plough has been informed by the FDA that its reference listed product Proventil produces the same therapeutic effects as the generic albuterol sulfate solution made by Dey Laboratories. This ruling is contrary to the citizen petition filed on behalf of Schering-Plough that Proventil contains an anti-microbial preservative not found in the Dey product. Another point in the filing is that asthma patients will experience different clinical effects from the two drugs since these posses different inactive ingredients.

Product standards, safety, & recalls, New Products/Services, Geographic, Proprietary Asthma Relief Preps, Schering-Plough Corp., Antiasthmatic agents, Dey Laboratories Inc., Proventil

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Cholestin case could change marketing

Article Abstract:

Pharmanex Inc. is expected to change the health product marketing industry because of a recent ruling on the dietary supplement Cholestin. The company can resume normal manufacturing operations, stated Utah Federal Judge Dale A. Kimball. Kimball ruled that the FDA cannot categorize the product as a drug. Pharmanex will then be able to resume importations of Chinese red yeast rice for production of Cholestin. The case was triggered by the FDA's earlier decision to label Cholestin as an unapproved new drug.

Marketing/Advertising Methods, Patents & copyrights, Specialty Vitamin Supplements NEC, Vitamins, Pharmanex Inc., Cholestin

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