What Is An Approved Animal Drug?

An approved animal drug has gone through the FDA's drug approval process. During this process, the agency reviews the information submitted by the pharmaceutical company about the animal drug. FDA approval means that the drug is safe and effective when used in accordance with the label. fda approval also ensures that the strength, quality and purity of the drug are consistent from batch to batch and that the drug's labeling is truthful, complete and not misleading.

How are animal drugs approved by the FDA?

The approval process for animal drugs is a collaborative effort between pharmaceutical companies and the FDA. In brief, the steps of the approval process are

• The pharmaceutical company gathers information about the safety and efficacy of a new animal drug. The company may need to conduct studies to obtain this information. For any studies that are conducted, the company analyses the results.

• Based on the information collected, the pharmaceutical company decides whether there is sufficient evidence that the drug meets the requirements for approval. The company must demonstrate that the drug is safe and effective for a specific use in a specific animal species. If the drug is used in food animals (such as cattle or chickens), the company must also demonstrate that it is safe for people to eat food from treated animals, such as meat, milk and eggs.

If the pharmaceutical company believes that the drug meets the requirements for approval, the company will submit an application for a new animal drug to the FDA. (For generic drugs, it is called an Abbreviated New Animal Drug Application.) The application includes all information about the drug and the proposed labelling.

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Are approved animal drugs the only drugs that can be legally used in animals?

In addition to approved animal medicines, there are two other types of animal medicines that can be legally marketed for use in animals, depending on the circumstances. These two categories are

Conditionally approved animal medicines. This only applies to certain animal medicines used for secondary species or, in exceptional cases, for primary species.

Indexed animal medicines. This applies only to certain drugs for minor species.

The FDA classifies horses, dogs, cats, cattle, pigs, chickens and turkeys as seven major species. All other animals, such as sheep, goats and hamsters, are minor species.

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What are the benefits of the FDA's drug approval process?

The benefit of the FDA drug approval process is that it ensures that approved animal drugs are safe, effective and of high quality. The pharmaceutical company has demonstrated that the drug is safe and effective in the particular animal species when used in accordance with the label. 

The label is written specifically for that species and includes all the necessary information for the safe and effective use of the drug as well as the risks associated with the drug. The pharmaceutical company has also demonstrated that the manufacturing process consistently produces a high quality drug.

Another benefit of the drug approval process is the FDA's ongoing post-marketing monitoring of approved animal drugs. The FDA also continues to monitor the drug's labeling, the drug's manufacturing process and the company's marketing communications related to the drug to ensure that the information is truthful and not misleading.

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