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Policies & Resources >>
Information About Generic Pharmaceuticals
Although there is no official US Food and Drug Administration (FDA) or
government agency list of narrow therapeutic index (NTI) drugs, the FDA does say
this:
Currently, the NTI designation is not a formal designation by the FDA.
A list of so called narrow therapeutic index drugs was prepared by the Center
for Drug Evaluation and Research in order to assist the FDA District Offices
in their testing program that came about because of problems with the generic
industry in the late 1980's.
This list, which was part of an appendix to the document "Scale-Up and Post-Approval
Changes for Intermediate Release Products" (SUPAC-IR) [found in full at
http://www.fda.gov/cder/guidance/cmc5.pdf]
is provided below for your information.
Narrow Therapeutic Range Drugs
- Aminophylline Tablets, ER Tablets
- Carbamazepine Tablets, Oral Suspension
- Clindamycin Hydrochloride Capsules
- Clonidine Hydrochloride Tablets
- Clonidine Transdermal Patches
- Dyphylline Tablets
- Disopyramide Phosphate Capsules, ER Capsules
- Ethinyl Estradiol/Progestin Oral Contraceptive Tablets
- Guanethidine Sulfate Tablets
- Isoetharine Mesylate Inhalation Aerosol
- Isoproterenol Sulfate Tablets
- Lithium Carbonate Capsules, Tablets, ER Tablets
- Metaproterenol Sulfate Tablets
- Minoxidil Tablets
- Oxtriphylline Tablets, DR Tablets, ER Tablets
- Phenytoin, Sodium Capsules (Prompt or Extended), Oral Suspension
- Prazosin Hydrochloride Capsules
- Primidone Tablets, Oral Suspension
- Procainamide Hydrochloride, Capsules, Tablets, ER Tablets
- Quinidine Sulfate Capsules, Tablets, ER Tablets
- Quinidine Gluconate Tablets, ER Tablets
- Theophylline Capsules, ER Capsules, Tablets, ER Tablets
- Valproic Acid Capsules, Syrup
- Divalproex, Sodium DR Capsules, DR Tablets
- Warfarin, Sodium Tablets
ER - Extended Release, DR - Delayed Release
For more information on narrow therapeutic index (NTI) drugs, click on the
links below.
http://ecapps.health.state.pa.us/pdf/ddc/nti.pdf
http://www.pronational.com/news/hsriskrv/NTIDrugs1Q1999.htm
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