Drugs FDA approved

Drug FDA approval Clinical utility Principal mode of action... 

Clomipramine (Anafranil) also a member of the tricyclic family, possesses similar pharmacology and antidepressant efficacy. This agent, however, has Food and Drug (FDA) approval only for use in the treatment of obsessive-compulsive disorder and is not included in this discussion of antidepressant drugs. 

Disulfiram and naltrexone are the only two drugs FDA approved for the treatment of alcohol dependence, although the clinical utility of these agents remains controversial. 

In summary, studies involving more than 4,000 patients provided consistent evidence of a beneficial effect of acamprosate in relapse prevention. On the basis of the drug s efficacy (as demonstrated by at least a doubling of the total abstinence rate in three European studies, two of which were of 12 months duration) and a good safety profile, the FDA approved the medica-... 

GHB has been used both for legitimate clinical and chnical research purposes and for a range of iUicit purposes. It was marketed legally in the United States until 1990, when the U.S. Food and Drug Administration (FDA) banned its sale to consumers. Except for the one indication described later in this section, GHB is a Schedule I controlled substance without other FDA-approved indications. The FDA has also declared y-butyrolactone (GBL) as a List I chemical and 1,4-butanediol (1,4-BD) as a Class I health hazard, practically designating these GHB precursors, which are also industrial solvents, as illicit and unapproved new drugs (National Institute on Drug Abuse 2000). 

The trial was run, and FDA approval, on the basis of the results, was obtained. The drug is currently commercially successful. Were it not for the new team member who commissioned this work, this trial would have failed— at a cost of 50 million and the loss of two years of revenue. Moreover, other efficiencies (fewer patients, faster recruiting, better understanding of patient and market stratification) would not have been realized. The cost (in time and resources) for modeling projects should be balanced by the benefits of increased likelihood of success (for a drug that will be successful) and of possibly avoiding a trial for a compound that cannot succeed. 

This section will review the phase III clinical trials of IV thrombolytic agents for acute ischemic stroke, organized by the type of agent and the time window from stroke onset to study drug delivery (Table 3.1). The 1995 National Institute of Neurological Disorders and Stroke (NINDS) rt-PA trial is presented first because it showed that IV rt-PA, given within 3 hours of stroke onset, reduced stroke-related disability. This trial was the basis for the United States Food and Drug Administration (FDA) approval for rt-PA for use in acute ischemic stroke. 

Both metoprolol and carvedilol are metabolized by the liver through cytochrome P-450 (CYP450)2D6 and undergo extensive first-pass metabolism. Bisoprolol is not as commonly used since it is not Food and Drug Administration (FDA)-approved for this use. 

Alteplase (rt-PA Activase) is an IV thrombolytic (fibrinolytic) that was approved for acute stroke treatment in 1996 based on the results of the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stroke Trial.10 The current American Stroke Association guidelines include alteplase as the only Food and Drug Administration (FDA) approved acute treatment for ischemic stroke and strongly encourage early diagnosis and treatment of appropriate patients.11... 

TABLE 9-8. Effects of Lipid-Lowering Drugs on Serum Lipids at FDA-Approved Doses... 

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