Rx Label Use Permissible Even If FDA Finds Drug Is Safe OTC – Attorney
This article was originally published in The Tan Sheet
Executive Summary
A drug sponsor may create and use alternative labeling saying it requires prescription distribution for a medicine even if FDA has determined the drug does not need to be limited to the Rx arena, according to attorney Andrew Krulwich of the Washington, D.C.-based law firm Wiley, Rein & Fielding
You may also be interested in...
OTC Labeling Adopted By FDA In Forced Switch Would Violate Regs Comments Say
FDA could not adopt a drug's approved OTC label from another country as acceptable U.S. OTC labeling without violating its own regulations, according to the American Association of Physicians & Surgeons and Competitive Enterprise Institute
Clarinex Clinical, Safety Characteristics Support OTC Use – WellPoint
The similar safety and efficacy profile of Schering-Plough's follow-on drug Clarinex (desloratadine) to other second-generation antihistamines makes it appropriate for OTC availability, WellPoint Health Networks asserts in an April 15 petition to FDA
OTC Sale Of Rx Allergy Drugs Would Be Safer, Cut Costs - Health Plan
Nonsedating antihistamines classified as prescription drugs would be more appropriately sold as OTCs, Blue Cross of California Pharmacy VP Rob Seidman maintains in Jan. 12 letters sent to marketers of the drugs.