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Branded vs Generic: The Saga Continues

The Pharmacist Perspective

Laurie Scudder, DNP, NP

Nov 29, 2012 MedScapeNews

Brand-Name vs Generic Agents: The Pharmacist Experience

Pharmacists, prescribers, and patients often voice concerns about the safety and efficacy of generic drugs that are substituted for brand-name drug products. No matter where they fall on the spectrum, most clinicians, however, acknowledge that they are here to stay. The US Food and Drug Administration (FDA) approves a generic substitute if it has proven to be "identical, or bioequivalent, to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use." [1]

The FDA’s Orange Book provides the latest information on generic approvals. Approved generic agents have been demonstrated to have therapeutic equivalence — although many clinicians have questioned whether that equivalence extends to all patients and all clinical scenarios. Jenny

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