Bristol OTC Pravachol Study Enrollment Does Not Match Indication - FDA
This article was originally published in The Tan Sheet
Executive Summary
Bristol-Myers Squibb may need to better demonstrate consumers' ability to make self-selection choices based on appropriate cholesterol levels in order to convince FDA that an OTC version of Pravachol is approvable.
You may also be interested in...
OTC Statin Physician Follow-Up Label Comprehension Not Shown - FDA
Merck and Bristol Myers-Squibb should design label comprehension studies that do not assume consumers would understand how to use Mevacor and Pravachol in an OTC setting, FDA's Karen Lechter, PhD, advised during joint meetings of the Nonprescription and Endocrinologic & Metabolic Drugs Advisory Committees July 13-14.
Pravachol OTC Marketing Retailer Involvement Anticipated By BMS
A Pravachol OTC marketing program designed to emphasize the "importance of keeping the doctor in the loop" would include point-of-purchase messages encouraging physician consultation, Bristol-Myers Squibb Rx-to-OTC Marketing Senior Director Patricia Kriger told FDA advisory committees July 14.
OTC Statin Physician Follow-Up Label Comprehension Not Shown - FDA
Merck and Bristol Myers-Squibb should design label comprehension studies that do not assume consumers would understand how to use Mevacor and Pravachol in an OTC setting, FDA's Karen Lechter, PhD, advised during joint meetings of the Nonprescription and Endocrinologic & Metabolic Drugs Advisory Committees July 13-14.