What Does It Mean When A Drug Is FDA Approved?

You have probably taken medicine at one point in your life to treat symptoms or to just boost your health. There are many types of medicines available to the public that range from over-the-counter (OTC) to prescription. Tylenol, or acetaminophen, is an example of an over-the-counter medicine.

You might wonder how drugs enter the market, and what entity does the due diligence to ensure that the drugs are effective and not dangerous. According to MedlinePlus, the United States Food and Drug Administration (FDA) oversees the OTC and prescription drug market to guarantee that the drugs you take not only work properly, but also are safe.

There are many FDA-approved drugs available that can help treat a variety of conditions. Healthline notes that several drugs — brand name Viagra, generic Viagra, brand name Cialis, generic Cialis, and brand name Stendra — are FDA-approved drugs for the treatment of erectile dysfunction. Viagra is an example of a prescription medicine. The FDA also approved its first vaccine for COVID-19 when it approved the Pfizer-BioNTech COVID-19 Vaccine (via FDA).

Here's everything you need to know about the FDA drug approval process and what it means when a drug is FDA approved.

FDA drug approval

According to the United States Department of Health and Human Services, while the United States Food and Drug Administration (FDA) does label medicines and supplements, prescription medicines and over-the-counter medicines have different requirements.

While prescription drugs must go through a regulation and approval process by the FDA that entails clinical trials on humans, over-the-counter (OTC) drugs are not required to be formally FDA-approved, but are still required to follow the FDA's guidelines for the medication's specific category. The FDA reviews the active ingredients and labeling of certain OTC medications to ensure that they are safe. A medication's label will tell you whether or not it has been FDA approved.

Cannabidiol, or CBD, is a great example of an over-the-counter (OTC) medicine. You may notice that while the FDA does not approve any currently marketed OTC CBD product, some companies claim to be compliant with the FDA's current good manufacturing processes (via Healthline).

The FDA states that there are over 20,000 approved prescription drugs. When a drug receives FDA approval, that means a few important things. First, FDA approval indicates that a drug has been evaluated to treat a given condition and compared to any other treatments — if available (via FDA).

FDA approval also means that the drug has gone through clinical trials to show that the drug's benefits, when used properly, are greater than the risks. Finally, FDA-approved drugs have labels that detail the risks of the drug and how to manage them.