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, Which conditions must be met for a drug to be approved as a generic substitution for the patented trade
name drug EXCEPT; what is the EXCEPTION?
a. chemically equivalent
b. biologically equivalent
c. therapeutically equivalent
d. similar in bioavailability - Correct Answer: a. chemically equivalent
In order to be marketed as the generic reformulation of a trade name product, the drug must be both
biologically and theraputically equivalent. A drug is biologically equivalent if the two formulations
produce similar concentrations of the drug in the blood and tissues. If the two drugs prove to have equal
therapeutic effects in a clinical trial, they are termed therapeutically equivalent. A drug is chemically
equivalent when two formulations of a drug meet the chemical and physical standards established by
the regulatory agencies. A drug can be chemically equivalent yet not biologically or therapeutically
equivalent, because it differs in bioavailability.
pg. 5
All are trade names of drugs except: which is the exception?
A. Lidocaine
B. Septocaine
C. Octocaine
D. Xylocaine - Correct Answer: A. Lidocaine
Lidocaine is the generic name of a common local anesthetic. The generic name is not capitalized, and is
considered the "official" drug name. Drugs have only one generic name. Septocaine, Octocaine, and
Xylocaine are all trade or brand names for lidocaine, and are capitalized. Trade names are registered as a
trademark as property of the registering company and is specific for that company, so there may be
many trade names for the same drug.
pg. 4