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The Authorized Generic

PRASCO Authorized Generics

Authorized Generics, Providing Patients with Brand Sameness

What is the difference between a generic and an Authorized Generic? According to the FDA, a generic drug is the same as a brand name drug in dosage, safety, strength, quality, performance, intended use and how it is taken. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product, however it is not required to have the identical inactive ingredients.1

According to the FDA, an Authorized Generic drug is a drug manufactured by the brand company and marketed as a generic with a trade name and packaging that differs from that of the original brand name drug.2
Simply put, the Authorized Generic is identical to the brand name drug, however it is packaged and marketed under the Prasco private label at a generic price.

An Authorized Generic provides the identical experience that the patient receives from the brand.  And it has the identical dosage, safety, strength, quality, performance, intended use, color, shape, taste, smell and mouth feel, and is identical in how it is taken. As a generic product, it contains the identical amounts of the identical active ingredient(s) as the brand name product AND UNLIKE a standard generic product, Authorized Generics contain the identical inactive ingredient(s) as the brand.

1 Food and Drug Administration. Facts About Generic Drugs. [Online] July 5, 2011. http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134010.htm

2 Food and Drug Administration. What is an Authorized Generic Drug? [Online] July 5, 2011. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Approval