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Cobalt Chromium Toxicity


What is the difference between Ondansetron and Zofran?

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Ondansetron is the generic counterpart of brand names Zofran®, Zofran® ODT and Zuplenz®. The term brand-name is synonymous with proprietary name and trade-name. Generic drugs are copies of brand-name drugs. According to the Food and Drug Administration (FDA), “A generic drug is identical — or bioequivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” Generic drugs are chemically identical to their brand-name forms and generally sold at significant discounts from the branded price. Zofran (brand) is chemically identical to ondansetron (generic), and vice versa, as exemplified by “Zofran® (ondansetron hydrochloride)”. Ondansetron hydrochloride (HCl) is the active ingredient in both Zofran tablets and Ondansetron tablets. For example, in both Zofran 4mg and Ondansetron 4mg, *each 4mg tablet contains 5 mg of ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Ondansetron and Zofran are equally effective (and potentially equally harmful). The FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.

Most brand-name drugs have a generic form. New drugs will have a drug patent when they are first made. Drug patents are typically protected for 20 years. GlaxoSmithKline (GSK), the manufacturer of Zofran, filed the first patent for the drug in 1986. Patents protect the company that initially developed the drug because they have exclusive rights to sell the drug while the patent is in effect. Other companies are not allowed to make and sell the drug until the patent expires. When the patent lapses, other drug companies can start selling a generic version of the drug. However, they must first test the drug and have the FDA approve it for distribution. Generic drugs are less costly than proprietary name drugs since they do not hold the trademark and just copy the formula for production purposes. Nevertheless, generic drugs must meet equivalent standards to the brand name drugs.

Drug companies must submit an Abbreviated New Drug Application (ANDA) to begin the process of making a generic drug. Once the FDA approves the ANDA, the company can manufacture and market the generic drug product to consumers. The FDA states, “Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug).” The ANDA process allows drug sponsors to essentially bypass expensive animal and clinical research on ingredients or dosage forms pre-approved for safety and effectiveness.  Therefore, costs to bring generic drugs to market are less.



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