Covetrus

11 2023 | Covetrus Brand Catalog Can't find what you are looking for? Contact your Covetrus North America representative. Both brand-name and private brand generic drugs must be manufactured to the same high- quality standards of the FDA. As consumer perceptions around private brand generic drugs change, it's important for veterinary hospitals to offer a variety of options to meet client demands. Although private brand generic drugs are commonplace in veterinary healthcare, there are still some misconceptions about these low-cost alternatives. For some hospitals, the question on whether to carry private brand drug options simply comes down to safety and efficacy: Do private brand drug alternatives provide equal profiles compared to "pioneer" (brand- name) drugs? The answer is an emphatic "yes"! Let's dispel a few common myths around private brand generic drugs and discover how offering these alternatives may help you and your clients save money on treatment — without sacrificing safety or efficacy. M Y T H 1 Brand-name drugs go through more rigorous testing for approval than private brand generic drugs. According to the Abbreviated New Animal Drug Application (ANADA) process, a private brand manufacturer must show that its generic drug is equivalent to the approved brand-name drug in three areas: • Active ingredient • Strength • Dosage regimen Each ingredient must also meet stringent quality standards and the private brand generic drug must demonstrate stability over the shelf life of the product. Blood-level bioequivalence studies are required by the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) for ANADA approval; these studies establish that any minor difference in bioavailability between the private brand generic and the brand-name drug is considered clinically insignificant. Blood-level bioequivalence studies compare a test product (private brand generic) with a reference product (brand-name drug) using parameters measuring and encompassing absorption, distribution, and depletion of the drug concentration over time. To determine bioequivalence between the products, the manufacturer of the private brand generic drug completes blood-level studies comparing its formulation with the brand-name formulation and reports to what extent the active ingredient concentrates in the blood and for how long. The average or mean results for the two products must not be significantly different. Designing, conducting, and analyzing a bioequivalence study can take up to three years to complete. The requirement for the bioequivalence study may be waived for certain private brand generic products, including parenteral or oral solutions, if certain criteria are met.

• Cover