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Generic Drug
, Generic Medication
Medications
Generic Medications bioequivalent to brand-name drugs
Warfarin
(
Coumadin
)
Levothyroxine
(
Synthroid
)
Cyclosporine
(
Sandimmune
)
Phenytoin
(
Dilantin
): extended release forms only
Digoxin
(
Lanoxin
)
Carbamazepine
(
Tegretol
)
Safety
Generic Drugs have similar efficacy and safety to trade name drugs despite lower cost and different manufacturers
Concerns about specific
Medication Safety
may be submitted to local pharmacist or to FDA
Most Generic Drugs are produced by manufacturers other than the brand/trade product
"Authorized
Gene
rics" are identical to brand/trade name and produced by the same manufacturer
Packaging and medication appearance often differs from the trade product
Historically U.S. Generic Drugs have been held to a high standard of equivalence and safety
However, FDA staffing cuts since 2024 has resulted in a back-log of testing and inspections
Dietrich (2025) Arch Toxicol 99(6):2239-41 +PMID: 40360856 [PubMed]
Most bioequivalent Generic Medications may be substituted for one another without significant adverse effects
Generic Drug absorption is allowed to differ up to 20-25% from trade name product
Small differences in absorption of different Generic Medications have low clinical impact for most drugs
However,
Exercise
caution with narrow
Therapeutic Index
medications (
Immunosuppressant
s,
Antiepileptic
s)
References
(2026) Presc Lett 33(9): 6
References
Dong (1997) JAMA 277:1205 [PubMed]
First (1998) Clin Transplant 12:518 [PubMed]
Handler (1998) Prev Cardiol 1:13 [PubMed]
Neutel (1998) Cardiovasc Rev Rep 19:49 [PubMed]
Schroeder (1998) J Clin Pharmacol 38:807 [PubMed]
Yacobi (1999) Clin Pharmacol Ther 65:389 [PubMed]
(1999) Med Lett Drugs Ther 41:47-8 [PubMed]
Resources
FDA bioequivalence testing
http://www.fda.gov/cder/ob/default.htm
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