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June 26: Pharmacy Fun Fact
Author(s):
What is the resource Approved Drug Products With Therapeutic Equivalence Evaluations commonly called?
What is the resource Approved Drug Products With Therapeutic Equivalence Evaluations commonly called?
Answer: The Orange Book!
The Orange Book was created as part of the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). It required that the FDA provide a publicly available list of safe and effective approved drug products with monthly supplements. This resource is also used by many states as the basis of generic drug substitution, and it is available electronically and through an app.
REFERENCE
FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book. Accessed June 22, 2020.
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