Why are some drugs available as both a prescription and an over-the-counter drug?
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.
- FDA Basics Metrics: December 2014
- FDA Basics Webinar: FDA CBER Mini-Sentinel Program
- Recall Process for FDA-Regulated Products
- FDA Basics Metrics: November 2014
- FDA Basics Webinar - November 24, 2014: Drug Shortages
- FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- FDA Basics Webinar June 30, 2014: Over-The-Counter Medicines and Driving
- Webinar Friday, May 23 - Packing A Healthy Lunch
- Webinar Tuesday, May 13 - Temporary Tattoos: Raising Consumer Awareness of Safety
- FDA Basics Webinar November 5, 2014: CVM’s Pet Food Reporting and Recall Process
- FDA Basics Metrics: October 2014
- FDA Basics Metrics: Septemeber 2014
- Who can I contact if my question wasn’t answered or if I have additional questions in the future?
- What Should I Do If I See Violations of FDA’s Tobacco Products Rules?
- FDA Basics Metrics: August 2014
- FDA Basics Metrics: July 2014
- FDA Basics Metrics: June 2014
- Where do I go to report problems with flea and tick products?
- What does FDA regulate?
- FDA Basics Metrics: May 2014
- FDA Basics Metrics: April 2014
- Who can I contact if my question wasn’t answered or I have additional questions in the future?
- FDA Basics Metrics: March 2014
- FDA Basics Metrics: February 2014
- What is the Reportable Food Registry?
How helpful was this information?