A new statement, “Approved by FDA,” provides assurance of the safety and effectiveness of animal drugs. This allows veterinarians, pet owners, and animal producers to now easily determine if an animal drug is FDA-approved. The FDA’s approval not only ensures that the drug is safe and effective for its intended use, but also that it is properly manufactured and adequately labeled and packaged.
All animal drugs that are FDA-approved have either a New Animal Drug Application (NADA) or an Abbreviated New Animal Drug Application (ANADA) number. This is required by the Food, Drug, and Cosmetic By Alex Gochenauer, PharmD, DICVP, FSVHP, FACA, Pharmacy Director CHD, CONTINUED FROM PAGE 1 Act. Labeling for approved animal drugs will include the six-digit application number as part of the following statement:
“Approved by FDA under NADA # XXXXXX” – for brand-name animal drugs or “Approved by FDA under ANADA # XXXXXX” – for generic animal drugs
If approved animal drugs do not carry the statement on their labeling, they are considered to be misbranded, and distributing these drugs violates the law. The FDA may take action, as appropriate, on drug labeling that does not follow the law.
By Alex Gochenauer, PharmD, DICVP, FSVHP, FACA, Clinical Staff Pharmacist
