Approved drugs

Double helix (DNA), 1103-1105 Doublet (NMR), 462 Dovvnfield (NMR), 445 Drugs, approval procedure for, 165 chiral, 320-322 origin of, 164... 

Anti-obesity Drugs. Table 1 Profile of drugs approved for long-term treatment of obesity... 

In theory, one could utilise GC-A ligands to lower blood pressure and to reduce blood volume as they increase the excretion of water and salt. Nesiritide, human recombinant BNP, is the first member of this new class of drugs approved for the initial intravenous treatment of acutely decompensated congestive heart failure. Whether nesiritide can be a valuable addition to the standard therapy of decompensated heart failure remains to be demonstrated. 

FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4000 drugs approved on the basis of safety alone between 1938 and 1962. 

The process of conducting dinical trials for drug approval may be broken down into three consecutive phases of ... 

Screening for phenotype rather than mechanism was the norm in the 1970s, an era at least as productive as the current in terms of drug approvals [12]. Screening for mechanism predominated by the 1990s and still does today. Most drugs entering... 

To date, clozapine remains the only drug with proven and superior efficacy in treatment-resistant patients, and it is currently the only drug approved for the treatment-resistant schizophrenic. Studies have shown a response of approximately 30% to 50% in these well-defined treatment-resistant patients. Clinical trials have consistently found clozapine to be superior to traditional antipsychotics for treatment-refractory patients, and it is efficacious even after nonresponse to other SGAs and in partially responsive patients. It is often rapidly effective even in those who have had a poor response to other medication for years. Recent studies have demonstrated that it has a beneficial effect for aggression and suicidality, which led to the Food and Drug Administration (FDA) approval for the treatment of suicidal behavior in people with psychosis.41... 

What are the variations in pharmacokinetics and pharmacodynamics of new generation psychotropics in different ethnic and cultural groups Are clinical drug trial data from specific population subgroups required before new drug approval is given ... 

FDA, in the CDBR 1998 Report to the Nation, has published data on generic drug approvals [76]. For 1998 the median approval time was 18.0 months compared to 19.3 in 1997, 23 in 1996, and 27 in 1995. At the same time the number of applications remained high at over 300 per year. 

F-D-C Reports Pharmaceutical Approvals Monthly. Pharmaceutical Approvals Monthly [99] provides coverage of U.S. drug approvals at the clinical level and includes the most recent FDA list of NDA approvals (originals, supplementals, and ANDAs). This specialized monthly also focuses on new drugs that have either been recently approved or... 

For drugs approved under accelerated approval regulations on the basis of a surrogate endpoint or an endpoint other than survival or irreversible morbidity, FDA may require a Phase IV study to confirm the drug s efficacy. Failure to show efficacy may result in withdrawal of approval. 

Total number of new drugs approved each year... 

New Drug Approval Process Clinical and Regulatory Management,... 

New Drug Approval Process Second Edition, Revised and Expanded, edited by Richard A. Guarino... 

If a government tightens up its drug approval policy it will have fewer type II errors but more type I errors, and vice versa. Therefore, an ideal drag approval policy should take into account both the costs and the benefits of a stricter or less strict policy when approving a pharmaceutical. Insofar as the costs and benefits stated above are important factors in the decision to approve or reject a drug, the role of economic evaluation is clear. 

Drug Approval date Date withdrawn Indication Sales at withdrawal... 

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