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FDA Approvals-New Drugs, Diagnostics and Devices


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Approved Drug-Electronic Orange Book-Search Approved Drug Products-

with Therapeutic Equivalence Evaluations, Current through February 2007
http://www.fda.gov:80/cder/ob/default.htm

Obsessive-Compulsive Disorder: FDA Approves Humanitarian Device Exemption for Deep Brain Stimulator for Severe Obsessive-Compulsive Disorder

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01959.html

Encephalitis-FDA Approves New Vaccine to Prevent Japanese Encephalitis

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01981.html

Kidney Cancer-FDA Approves Drug for an Advanced Form of Kidney Cancer

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01980.html

Biologic-FDA CDER Drug and Biologic Approvals for Calendar Year 2006

Updated through October 31, 2006
http://www.fda.gov/cder/rdmt/InternetNDA06.htm

Therapeutic Equivalence-FDA Approved Drug Products with Therapeutic Equivalence Evaluations

Orange Book
http://www.fda.gov/cder/orange/default.htm

Cystic Fibrosis-FDA Approves Inhaled Antibiotic for Management Of Cystic Fibrosis Patients

Cystic fibrosis is an inherited condition that causes thick mucous secretions in the lungs, resulting in severely diminished lung function and chronic lung infections...
http://www.fda.gov/bbs/topics/NEWS/NEW00610.html

Skin Cancer-FDA Approves New Drug for Skin Cancer, Zolinza

Evidence of Zolinza's safety and effectiveness was developed in two clinical trials
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01484.html

Vaccine-FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants

Infection with rotavirus is a leading cause of severe diarrhea in infants and young children in the United States and worldwide
http://www.fda.gov/bbs/topics/news/2006/NEW01307.html

Pulmonary-FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension

(FDA) today approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01653.html
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