US Pharm. 2006;8:88.

Plans Announced for the Approval of OTC Emergency Contraception
FDA announced that it is working with Duramed to discuss a framework for the approval of Plan B (levonorgestrel) as an OTC emergency contraceptive. Both parties have agreed to meet immediately to resolve policy issues such as age restrictions and plans for marketing, distributing, and monitoring the drug.

According to an FDA press release, FDA's foremost concerns are establishing a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use.

OTC Sunscreen Product Approved
FDA has approved Anthelios SX, an OTC sunscreen from L'Oreal indicated for the prevention of sunburn and for protection against ultraviolet B (UVB) and UVA rays. Anthelios SX has a sun protection factor of 15 and contains a combination of three active ingredients: ecamsule, avobenzone, and octocrylene.

"While this product provides protection from harmful UVA and UVB rays, FDA continues to recommend that in addition to using a sunscreen, consumers protect themselves from sun exposure by limiting time in the sun and wearing protective clothing," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.

FDA Warns Against ED "Supplements"
FDA has issued a warning against purchasing and/or consuming Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON--products promoted as "dietary supplements" for the treatment of erectile dysfunction (ED) that have not been approved by FDA nor proved to be safe and effective. These products "contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products," stated Dr. Galson. He noted that consumers that use these products for ED may not know that they contain ingredients that can interact with medications, causing decreased blood pressure.

Baxter Pumps Withdrawn
Baxter Healthcare Corp. has agreed to stop manufacturing the Colleague Volumetric Infusion Pump and the Syndeo Patient Controlled Analgesic Syringe Pump in the U.S. until manufacturing deficiencies have been corrected, FDA recently announced. Additionally, Baxter states that it will not distribute the pumps until they are made in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. Baxter will continue to provide routine maintenance and replace components, parts, or accessories for pumps sold before October 12, 2005.

Generic Sertraline Approved
The first generic versions of Pfizer's Zoloft (sertraline and sertraline hydrochloride) have been approved by FDA. Sertraline tablets are indicated for the treatment of major depressive disorder in adults, while sertraline hydrochloride is approved for the treatment of major depressive disorder and some anxiety-related disorders.

In 2005, Zoloft was the sixth highest-selling brand-name drug in the United States, with sales totaling $2.56 billion.

Test for Congestive Heart Failure Approved
A test that can determine if a patient is experiencing congestive heart failure, the i-STAT BNP cartridge, has approved by the FDA. The test measures the level of brain natriuretic peptide that is sent into the bloodstream by the heart during congestive heart failure.

The test can be used in various settings, including emergency departments, heart failure clinics and observation units, and laboratories.

New Director Added to Pandemic Threat Team
Dr. Mark Goldberger has been appointed as Medical Director for Emerging and Pandemic Threat Preparedness in FDA's Center for Biologics Evaluation and Research (CBER). Dr. Goldberger will be part of CBER's Senior Leadership Team and will chair the Pandemic Influenza Steering Committee. He will plan, coordinate, and implement activities related to the development and evaluation of products for emerging and pandemic threats.

Dr. Goldberger's "regulatory and public health experience with a wide range of infectious diseases and emerging threats, including influenza, SARS, pandemic influenza, and West Nile Virus, will be a major asset in our strategic response," said Dr. Jesse L. Goodman, Director of CBER.

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