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Drugs

February 5: I am confused as to why some drugs are available as both a prescription and an over-the-counter drug. Can you explain?

CDER Director's Mailbag

A medication that is marketed as both a prescription medication and an OTC medicine may contain the same active ingredient; however, the dosage strength and form, the dosing regimen or the indications may differ between the prescription and the OTC versions. For example, the prescription version of the drug may come in a higher strength and may have to be taken more often than the OTC version of the drug.

When a medicine is available as both prescription and OTC, it is usually first approved as a prescription drug, and the company later applies to have an OTC version approved.

Page Last Updated: 02/26/2016
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