FDA

XIENCE V, Only Drug Eluting Stent to Demonstrate Superiority Over Market-Leading Stent in Clinical Trials, Now Available in United States for Treatment of Coronary Artery Disease

Abbott Park, Illinois, July 2, 2008 -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE™ V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the only drug eluting stent to have demonstrated superiority over Boston Scientific's TAXUS® paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. XIENCE V will be launched in the United States immediately.    » read more »

06/17/2008 -- BOSTON – Senator John Kerry today urged the Food and Drug Administration (FDA) to explain the long delays in getting new generic prescription drugs out on the market.

People across Massachusetts and throughout the nation are facing rising costs for medications they depend on every day. For some, especially the elderly and low-income families, affordable generic drugs can be the difference between life and death.

The FDA is currently required to review a generic drug application within 180 days. However, the median approval time for a generic drug application now takes longer than 21 months - well beyond the 180 day requirement. These delays create a serious backlog of applications.    » read more »

Record-Breaking Agreement Requires Company to Submit Ads to FDA Prior to Airing

May 20, 2008 -- Chicago - Illinois Attorney General Lisa Madigan today announced a landmark financial settlement with Merck and Company, Inc., that also requires the pharmaceutical manufacturer to submit television drug advertisements to the U.S. Food and Drug Administration (FDA) for review before their broadcast.    » read more »

Boise – The State of Idaho will receive more than $1.1 million as a result of a consent judgment with Merck and Company, Inc., Attorney General Lawrence Wasden announced today. Wasden’s office filed a consent judgment resolving a three-year investigation by 30 states concerning the company’s deceptive promotion of the drug Vioxx.

The judgment, filed Tuesday in Fourth District Court in Ada County, will largely restrict Merck’s ability to deceptively promote any Merck product.    » read more »

Company was under investigation for marketing of anti-inflammatory drug

May 20, 2008 -- TALLAHASSEE, FL - Florida Attorney General Bill McCollum today filed a stipulated consent judgment with Merck and Company, Inc. resolving a three-year investigation that targeted the company’s promotion of the prescription drug Vioxx.

Merck Vioxx

The agreement provides $58 million to the 30 participating states, of which Florida’s share will be more than $3.5 million. The judgment, filed today in the Broward County Circuit Court and pending court approval, will largely restrict Merck’s ability to promote any Merck product in a manner that may be deceptive.    » read more »

May 20, 2008 -- SAN DIEGO -- California Attorney General Edmund G. Brown Jr. today announced a “groundbreaking settlement” with Merck & Co. which requires the pharmaceutical manufacturer to obtain Federal Drug Administration approval before running any television drug advertisements for new pain medications.

“Merck’s aggressive television advertising convinced hundreds of thousands of consumers to seek Vioxx prescriptions before the drug’s risk were fully understood,” Attorney General Brown said. “Today’s groundbreaking settlement prevents Merck from releasing new television drug advertisements without obtaining federal approval.”    » read more »

Tainted Heparin Linked To 81 Deaths; Blood Thinner Originating From China Contained Deadly Contaminant

April 22, 2008 -- WASHINGTON, DC--U.S. Senator Charles E. Schumer (D-NY) announced Tuesday he will introduce legislation this week establishing a modern track-and-trace system for all prescription drugs sold in the United States, a move he said would cut down on the contamination of popular patient medicines like the embattled blood thinner, heparin.

Heparin syringe: Photo by flaviab (CC)    » read more »

April 09, 2008 -- Following a federal recall of two dietary supplements, the Kentucky Department for Public Health (DPH) has issued a health advisory for consumers who may have ingested the products and could be at risk for illness.

The U.S. Food and Drug Administration on Friday reported that two products of the Total Body Formula dietary supplement line have been recalled due to health concerns: Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.    » read more »

March 28, 2008 -- The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.

The hearing aids pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.    » read more »

Distributor recalls dietary supplement products after reports of adverse reactions

March 27, 2008 -- The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.    » read more »

March 19, 2008 -- WASHINGTON, DC— Today, Senator Edward M. Kennedy, Chairman of the Health, Education, Labor and Pensions Committee, released the following statement in response to the FDA’s announcement that they have identified the contaminant in the blood thinner heparin, a chemical compound called oversulfated chondroitin sulfate. Senator Kennedy will be sending letters to the FDA and industry later today.    » read more »

Agency on path to establish offices in China

March 14, 2008 -- In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.    » read more »

Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place

February 8, 2008 -- The U.S. Food and Drug Administration (FDA) today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.    » read more »

FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified

February 11, 2008 -- The U.S. Food and Drug Administration (FDA) announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.    » read more »

Feb. 8, 2008 -- Statement of Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen:    » read more »