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What is an Approved Drug?

By Felicia Dye
Updated May 17, 2024
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An approved drug is one which is deemed acceptable for specific purposes. Approval is usually granted by a government authority, such as the US Food and Drug Administration (FDA). In most instances, a drug has to be extensively tested before it is approved for marketing, distribution, and consumption. The term “approved drug” can also be used to refer to medications for which an insurance provider will pay.

Selling drugs is normally more complicated than developing a medication that allegedly cures or treats a particular problem. After a formula is developed for a drug, it usually needs to be thoroughly tested for a given condition. The pharmaceutical company or drug maker then presents the drug to the proper authority and applies for permission to distribute the drug. Drug approval is usually a matter of federal jurisdiction.

Before a government agency will approve a drug, they will generally require solid evidence that the medication is effective and that it is not harmful. It is important to understand that an approved drug generally receives consent to be marketed for specific purposes. Testing should demonstrate the effectiveness of a drug for each condition that it will be marketed toward. This means that a drug which is approved for anxiety is not allowed to be marketed as a remedy for menstrual cramps, unless it was tested and approved for both conditions.

Approval is usually required for both prescription and non-prescription drugs. This is because medications in either category have the potential to do harm to individuals. Certain categories of medication, however, may not require approval. Items such as herbal extracts and vitamins may be considered dietary supplements and are, therefore, not subject to drug approval regulations.

Although regulatory agencies such as the FDA do their best, their approval processes are not always 100 percent effective. There have been numerous cases where approved drugs have been placed on the market and sold for extended periods of time before they are later banned. This is usually due to the revelation of adverse side effects.

Insurance providers often have their own approved drug lists. Sometimes physicians prescribe unorthodox treatments. Although, they may be effective, an insurance provider may refuse to cover the cost of the drugs for the prescribed purpose. For example, a doctor may inform her patient that birth control will help to treat her acne, but for this purpose the insurance company may not recognize birth control as an approved drug. In other instances, an insurance company’s refusal to cover costs may stem from the fact that a drug is too expensive and cheaper alternatives exist.

WiseGEEK is dedicated to providing accurate and trustworthy information. We carefully select reputable sources and employ a rigorous fact-checking process to maintain the highest standards. To learn more about our commitment to accuracy, read our editorial process.
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