FDA NEWS

FDA Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.

FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.

FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Device Identifies Fatty Deposits in Coronary Arteries
A new medical device allows doctors to see the plaque buildup on the wall of coronary arteries. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots.

Manufacturer Removes Remaining Stocks of Trasylol
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process.

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death.

FDA Safety Update: Asthma Medications
May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications.

Combating Antibiotic Resistance
Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics.