Generic drugs Administration

W. P. Adams and G. J. P. Singh. Guidance Topical dermatology corticosteroids In vivo bioequivalents, Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration, 1995. 

Department of Health and Human Services, Food and Drug Administration (DHHS), and Center For Drug Evaluation and Research, Guidance for industry court decisions, ANDA approvals, and 180-day generic exclusivity under the Hatch-Waxman amendment to the Federal Food, Drug, and Cosmetic Act, DHHS, Washington, DC, March, 2000. 

AstraZeneca launched omeprazole in 1988. It is a safe and effective drug for acid reflux, functioning as a proton pump inhibitor. However, the patent has expired and AstraZeneca has to compete against generics. The company developed the active isomer and called it esomeprazole. It was approved by the Mutual Recognition process in Europe in July 2000, and by the US Food and Drug Administration in February 2001. The chemical formulas for omeprazole and esomeprazole are shown below. 

American Association of Retired Persons American Health Care Association American Hospital Association American Medical Association American Nurses Association American Pharmaceutical Association American Society of Health-System Pharmaeists American Society for Healthcare Risk Management Department of Veterans Affairs Food and Drug Administration Generic Pharmaceutical Industry Association Institute for Safe Medication Practices... 

On January 23,2006, a scientific advisory panel to the Food and Drug Administration, FDA, in the United States recommended that a weight-loss drug previously available by prescription only be approved for sale over the counter (OTC). The drug in question is known by the generic name orlistat and it has been marketed in the United States by Hoffmann-La Roche since 1999 as Xenical. The OTC product is known as Alii and is marketed by GlaxoSmithKline. 

Approved quinolones as of February 2006 Generic available Marketed in the United States by Oscient. Source. U.S. Food and Drug Administration (FDA) website www.fda.gov/cder... 

The other computation is that of relative bioavailability. This calculation is determined when two products are compared to each other, not to an intravenous standard. This is commonly calculated in the generic drug industry to determine that the generic formulation (e.g., a tablet) is bioequivalent to the original formulation (e.g., another tablet). Thus, bioavailability is not routinely calculated in an individual patient but reserved for product development by a drug manufacturer. However, it is important to have an idea of how formulations or routes of administration differ with respect to bioavailability so as to allow proper dosage adjustment when changing formulations or routes of administration. 

Comparison between Generic Drug and RLD-505(j)(2)(A) 1. Conditions of use 2. Active ingredients 3. Inactive ingredients 4. Route of administration... 

Crawford, L. M., Acting Commissioner of the Food and Drug Administration, in a Speech to the Generic Pharmaceutical Association on February 26, 2005, available http //www. fda.gov/oc/speeches/2005/GPhA0301.html, accessed Apr. 23,2005. 

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs, Electronic orange book Approved drug products with therapeutic equivalence evaluations, available http //www.fda.gov/cder/ob/default.htm, accessed Apr. 21, 2005. 

R., Hauck, W.W. et al., An individual bioequivalence criterion regnlatory considerations, Stat. Med. 19, 2821-2842, 2000 Meyer, M.C., United States Food and Drug Administration requirements for approval of generic drug products, J. Clin. Psychiatry 62 (Suppl. 5), 4-9, 2001 Temple, R., Policy developments in regulatory approval, Stat. Med. 21, 2939-3048, 2002 Gould, A.L, Substantial evidence of effect, J. Biopharm. Stat. 12, 53-77, 2002 Chen, M.L., Panhard, X., and Mentre, F, Evaluation by simulation of tests based on nonlinear mixed-effects models in pharmacokinetic interaction and bioequivalence cross-over clinical trials, Stat. Med. 24,1509-1524,2005 Bolton, S., Bioequivalence studies for levothy-roxine, AAPS J. 7, E47-E53, 2005. 

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