Food and Drug Administration list

Sources (1) Food and Drug Administration. List of Orphan Products Designations and Approvals. http //www.fda.gOv/ohrms/dockets/dailys/00/mar00/030100/lst0094.pdf [accessed September 21, 2007]. (2) Food and Drug Administration. Ontak. http //www.fda.gov/ medwatch/SAFETY/2006/Mar%20PIs/Ontak PI.pdf [accessed September 21,2007]. 

Food and Drug Administration. List of Approved Drugs for Which Additional Pediatric Information May Produce Health Benefits in the Pediatric Population, Docket No. 98N-0056, U.S. Department of Health and Human Services Washington, DC, May 20, 1998. 

Formic acid in 85% concentration is not flammable, and diluted formic acid is on the US Food and Drug Administration list of food additives. The principal danger from formic acid is from skin or eye contact with the concentrated liquid or vapors. The US OSHA Permissible Exposure Level (PEL) of formic acid vapor in the work environment is 5 parts per million parts of air (ppm). 

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 approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

Colorants were the first food additives subjected to governmental regulation in the United States (US). After successive toxicological evaluations, the Food and Drug Administration established a list of permitted colorants and lakes. Only 7 synthetic pigments (and 2 others with restrictions) and 6 of their lakes are now permitted as food colorants in the US while 17 are permitted in the European Union (EU) see Table 7.3.L - ... 

Table 10 lists United States Food and Drug Administration (FDA) submissions in 2000 for commercial GMOs, including the food, gene, source and intended... 

Parenteral iron therapy currently is available in three different formulations, which are listed in Table 63-3. Iron dex-tran was the first parenteral iron formulation to be approved, followed by ferric gluconate, and then iron sucrose. Although these newer agents are only approved by the Food and Drug Administration (FDA) to treat anemia associated with CKD in patients receiving erythropoietin products, they are effective in treating iron-deficiency anemia as well. Iron dextran is FDA approved for treating documented iron deficiency in patients who are unable to tolerate the oral formulation. 

In its continuing effort to improve the safety and efficacy of drugs in the pediatric population, the U.S. Food and Drug Administration (FDA) has defined five subgroups of this population based on age. Each subgroup is not homogeneous but does contain similar characteristics that are considered milestones in growth in development. The FDA classifications are listed in Table 1. 

A worktable that can be used to calculate a cumulative exposure estimate on a site-specific basis is provided in Table 2. To use the table, environmental levels for outdoor air, indoor air, food, water, soil, and dust are needed. In the absence of such data (as may be encountered during health assessment activities), default values can be used. In most situations, default values will be background levels unless data are available to indicate otherwise. Based on the U.S. Food and Drug Administration s (FDA s) Total Diet Study data, lead intake from food for infants and toddlers is about 5 pg/day (Bolger et al. 1991). In some cases, a missing value can be estimated from a known value. For example, EPA (1986) has suggested that indoor air can be considered 0.03 x the level of outdoor air. Suggested default values are listed in Table 3. 

Food and Drug Administration . Contains information on food additives and premarket approval, including guidance in designing and interpreting studies to assess safety ( FDA Redbook ). 

Phenol is listed on the Food and Drug Administration s EAFUS (Everything Added to Foods in the United States) List (FDA 1998a), and is approved as a component of food packaging materials (FDA 1998b, 1998c, 1998d). 

Components of F-[IV entry and targets for entry inhibition including coreceptor blockers. There are many different stages of viral entry and each of these is specifically susceptible to antagonism by specific compounds. The compounds listed above are in clinical development with the exception of enfuvirtide, which was approved by the Food and Drug Administration (FDA). (Reprinted with permission from Dr. Robert W. Dorns. Available at http //cHnicaloptions.com. Accessed August 25, 2005.)... 

Food and Drug Administration. Guidance for Industry, Forms For Registration of Producers Of Drugs and Listing Of Drugs In Commercial FDA, Rockville,... 

Chamomile appears very low in toxicity. It has been listed as Generally Regarded as Safe (GRAS) by the Food and Drug Administration (Tyler 1994). Adverse reactions may include allergic reactions to the pollen in the flowers (Kowalchick and Hylton 1987 Subiza et al. 1990). 

The list of drugs to be discontinued is continuously updated at the US Food and Drug Administration website, 2004,... 

The U.S. Food and Drug Administration has now approved about 50 drugs prepared by recombinant DNA techniques for use in humans. An additional 200 products are at various stages of development and testing. Some of the approved products and the uses for which they are permitted are listed in the chart on page 71. 

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