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Some New FDA Apporvals


The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.


The FDA is reminding health care professionals about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodiumand related products (valproic acid and divalproex sodium) during pregnancy. The FDA will be working with the manufacturers of these products to address labeling changes.

Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.

Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant.

For more information please visit:  Valproate 


The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.


The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

HAE is caused by a defect in the blood protein C1 esterase-inhibitor, which plays a role in regulating how certain immune system and blood clotting pathways function. Decreased function of this protein can lead to rapid and serious swelling of the face or other parts of the body, which may result in permanent disfigurement, disability or death.  Swelling of thedigestive tract may cause excruciating abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation. About 10,000 people in the United States have HAE.

Kalbitor is a liquid that is intended to be injected under the skin for patients age 16 and older who experience HAE attacks.

For more information, please visit: Kalbitor


World AIDS Day was established 21 years ago by the World Health Organization to focus awareness and attention on the AIDS epidemic. It’s an important reminder that HIV and AIDS are still with us, still spreading, and still claiming lives.

World AIDS Day is also a time to remember those who have a place in our lives, and are no longer here. Those who lost the battle against AIDS, but remain in our minds, and our hearts.

World AIDS Day is a time for reflection, and also for celebration.

FDA plays a vital role in the fight against HIV/AIDS.  The agency provides review and oversight in areas related to drugs, biologics and medical devices for the prevention, diagnosis and treatment of HIV/AIDS and AIDS-related conditions. FDA helps to ensure the safety of the blood supply, is involved in surveillance and quality assurance of barrier products that can help preventtransmission of HIV, and plays a role in the search for workable preventive and therapeutic vaccines. Food safety also plays an important role in the health of people infected with HIV in the United States.

To support the President’s Emergency Plan for AIDS Relief  (PEPFAR) , FDA developed special expedited review procedures that allow FDA to quickly review applications for generic formulations of drugs to treat HIV, as well as unique fixed-dose combinations, or new dose formulations of approved drugs. During 2009, reached a milestone of more than 100 tentative approvals for PEPFAR to help make treatments more available in countries served by the program.

The work of people within FDA has contributed to tangible and profound changes in access to medical treatment for people living with AIDS, not just in the United States, but globally as well, through PEPFAR. Lower cost therapies, improved formulations that increase drug adherence, and new pediatric formulations have brought positive changes to the people of the developing world that were only dreamed of only a few years ago.

Richard Klein 
Office of Special Health Issues 
Food and Drug Administration

Kimberly Struble 
Division of Antiviral Drug Products 
Food and Drug Administration


December 4, 2009 - Posted by | 1

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