What Does it Mean if a Drug is FDA Approved?

We’ll look at the legal definition of a drug and what requirements a drug has to meet in order to be FDA approved.

November 19, 2021
3 min read

Article Highlights

  • There are three types of drugs: FDA approved human drugs, FDA approved animal drugs, and unapproved drugs.

  • A New Animal Drug Application (NADA) is required to obtain approval of an animal drug from the FDA.

  • The FDA’s approval of a NADA means that the submitted data fulfills FDA requirements for use of the drug as indicated in the drug’s labeling.

This article is the first in a series exploring veterinary drug regulations. To start the series, we’ll begin with an overview of what a drug is, the differences between approved and unapproved drugs, and how a drug gets approved by the U.S. Food and Drug Administration (FDA).

What is a drug?

In the United States, drugs are regulated by the FDA according to the Federal Food, Drug, and Cosmetic Act (FD&C). There are three categories of drugs: FDA approved animal drugs, FDA approved human drugs, and unapproved drugs. FDA approved human and animal drugs meet the FDA’s standards for safety, efficacy, and manufacturing.

Unapproved drugs, whether they be unapproved animal drugs or unapproved human drugs, do not fulfill the FDA’s stringent standards for drug approval. This category also includes compounded animal drugs that have been compounded from unapproved drugs. This category of compounded drugs is illegal under FDA regulations. In short, all human and veterinary drugs must meet the FDA’s drug approval standards for safety, effectiveness, and manufacturing. If not, the drugs are considered unsafe under the FD&C Act and may not legally be marketed for use in animals or humans.

How does a drug get FDA approved?

The key component to getting an animal drug approved is a New Animal Drug Application (NADA). The NADA contains information on the drug’s chemistry, composition, intended effects, side effects, and intended label description. The drug sponsor (the party that submits the NADA) must include data to demonstrate the drug’s safety and efficacy. “Safety” of a drug refers to the safety of the animal receiving the drug, safety of food products derived from the animal (for food producing animals only), and safety of the person administering the drug to the animal. For a drug to be considered by the FDA to be “effective,” it must achieve what is claimed in the product’s labeling. Upon reviewing the NADA, the FDA determines whether all drug approval criteria have been fulfilled and, if so, the NADA for the drug is approved.

Typically, it takes drug sponsors years to collect the body of data required to obtain full NADA approval from the FDA. In certain cases, a drug can obtain conditional NADA approval from the FDA. If a drug is eligible for conditional approval, it can be approved without a full body of effectiveness data to support the NADA; however, all other components required for NADA approval, including safety and manufacturing, must be fulfilled. A conditionally approved NADA will lose its FDA approval status if the sponsor does not submit the remaining effectiveness data within a five-year period following initial approval.

So, what does it mean once a drug is FDA approved?

Once a drug is approved, it means that the FDA has concluded that the drug is safe and effective when used as directed in the product’s labeling for the disease indication(s) described in the product’s labeling. If a drug sponsor wants to obtain a new disease indication for the product, a supplemental NADA application must be submitted for FDA’s review and approval.

Authors: