Covetrus

11 2022 | Covetrus Brand Catalog Can't find what you are looking for? Contact your Covetrus North America representative. Dispelling common myths of private brand drug alternatives M Y T H 2 A private brand generic drug can have up to 20% less active pharmaceutical ingredient. To conduct the bioequivalence study, the same dosage is used for both the brand-name and private brand formulations. The FDA-CVM considers two products bioequivalent if the mean peak concentration and area under the curve are not significantly different when applying a 90 percent confidence interval approach. The acceptable limits are that the private brand product mean must be within 80 percent to 120 percent (untransformed data) or 80 percent to 125 percent (log-transformed data) of the mean of the reference product. This allows for individual animal variation in the live animal study. This does not mean that the private brand generic drug is allowed to have 20 percent less active ingredient than the brand-name drug. Private brand generic drugs must be formulated to contain the same amount of active ingredient as brand-name products. M Y T H 3 Private brand generic drug manufacturing facilities and processes do not have to meet the same standards as those for brand-name drugs. Both brand-name and private brand generic drugs must be manufactured to the same high-quality standards of the FDA. They all must be manufactured in FDA-inspected facilities, must meet current "Good Manufacturing Practices" guidelines and must be shown to be safe and effective. M Y T H 4 Private brand generic drug manufacturers do not monitor their drugs for adverse events and quality complaints post-approval like brand-name drug manufacturers do. The FDA's post-approval requirements for brand-name drugs and private brand generic drugs are identical: • Pharmacovigilance (adverse event and quality complaint) monitoring/reporting • Reporting of manufacturing changes • Ongoing stability testing • Submission to FDA of advertising and promotional materials 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. Both brand-name and private brand generic drugs must be manufactured to the same high- quality standards of the FDA.

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