Continuing Education

Published through an educational grant from WYETH-AYERST LABORATORIES
TRENDS IN PHARMACY AND PHARMACEUTICAL CARE

This is part of an ongoing CE program of The University of Mississippi School of Pharmacy and DRUG TOPICS.
The University of Mississippi School of Pharmacy is approved by the American Council on Pharmaceutical
Education as a provider of continuing pharmaceutical education. Accredited in every state requiring CE. ACPE # 032-999-01-002-H01

This lesson is no longer valid for CE credit after 12/31/03.

CREDIT:

This lesson provides two hours of CE credit and requires a passing grade of 70%.

OBJECTIVES:

Upon completion of this article, the pharmacist should be able to describe for the new molecular entities approved in 2000:

• Therapeutic use

• Mechanism of action

• Pharmacological properties

• Potential drug interactions

• Recommended route of administration and dosing schedule

• Dosage forms and storage properties

• Counseling information for patients

GOAL:

To provide information about all the new molecular entities approved in 2000

COVER STORY

NEW DRUG APPROVALS OF 2000—Part 1

By W. Marvin Davis, Ph.D.

Professor, Department of Pharmacology, Research Institute of Pharmaceutical Sciences University of Mississippi, School of Pharmacy and

Michael C. Vinson, Pharm.D., M.S.,

Associate Professor, Department of Pharmacy Practice, Bureau of Pharmaceutical Services, University of Mississippi School of Pharmacy

Special thanks to Priscilla McCoy of McCoy Associates Strategic Naming and Branding for assistance in developing the pronunciation guides.

The year 2000 saw 27 new molecular entities (NMEs) approved. But by the end of the year, an early approval, alosetron (Lotronex, Glaxo Wellcome), a treatment for irritable bowel syndrome, was removed from the market. The Food & Drug Administration had received postmarketing reports of 49 cases of ischemic colitis and 21 cases of severe constipation.

The year was also marked by the addition of three antidiabetic medications—an oral hypoglycemic and two variations of insulin. Also making its debut was a representative of the first entirely new antibiotic class introduced in 35 years. The military also got into the act. It obtained approval for a topical product designed to provide protection against chemical warfare agents. Perhaps the most controversial approval was that of mifepristone, also known as RU-486.

Other approvals included a couple of anticoagulants, a new local anesthetic for dental use, and an over-the-counter topical therapy for cold sores. Part 1 covers 13 NMEs. Part 2, which will appear in the March 5 issue, will cover the remaining NMEs and summarize the six new biological agents approved last year.