

Description of Medical Areas
About the FDA Approved Listings
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Drugs Approved by the FDA (2008)
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The following drugs have been approved this year by
the Food and Drug Administration.
Cardiology/Vascular Diseases
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Cleviprex (clevidipine); For the treatment of hypertension when oral therapy is not feasible or not desirable; The Medicines Company; Approved August 2008
Dental/Maxillofacial Surgery
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Dermatology/Plastic Surgery
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Entereg (alvimopan); For the treatment of postoperative ileus; GlaxoSmithKline; Approved May 2008
Sancuso (granisetron); For the treatment of chemotherapy-induced nausea and vomiting; ProStrakan; Approved September 2008
Tysabri (natalizumab); For the maintenance treatment of moderate to severe Crohn’s disease; Biogen IDEC; Approved January 2008
Nplate (romiplostim); For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura; Amgen; Approved August 2008
Immunology/Infectious Diseases
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Cinryze (C1 Inhibitor (Human)); For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema; Lev Pharmaceuticals; Approved October 2008
Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 2008
Tysabri (natalizumab); For the maintenance treatment of moderate to severe Crohn’s disease; Biogen IDEC; Approved January 2008
Orencia (abatacept); For the treatment of Juvenile Idiopathic Arthritis; Bristol-Myers Squibb; Approved April 2008
Xenazine (tetrabenazine); For the treatment of chorea due to Huntington's disease; Prestwick Pharma; Approved August 2008
Xenazine (tetrabenazine); For the treatment of chorea due to Huntington's disease; Prestwick Pharma; Approved August 2008
Durezol (difluprednate); For the treatment of inflammation and pain associated with ocular surgery; Sirion Therapeutics; Approved June 2008
Vimpat (lacosamide); For the treatment of partial-onset seizures in adults with epilepsy; Schwarz Pharma; Approved October 2008
Xenazine (tetrabenazine); For the treatment of chorea due to Huntington's disease; Prestwick Pharma; Approved August 2008
Xenazine (tetrabenazine); For the treatment of chorea due to Huntington's disease; Prestwick Pharma; Approved August 2008
Sancuso (granisetron); For the treatment of chemotherapy-induced nausea and vomiting; ProStrakan; Approved September 2008
Durezol (difluprednate); For the treatment of inflammation and pain associated with ocular surgery; Sirion Therapeutics; Approved June 2008
Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 2008
Alvesco (ciclesonide); For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents; Nycomed; Approved January 2008
Cinryze (C1 Inhibitor (Human)); For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema; Lev Pharmaceuticals; Approved October 2008
Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 2008
Orencia (abatacept); For the treatment of Juvenile Idiopathic Arthritis; Bristol-Myers Squibb; Approved April 2008
Sancuso (granisetron); For the treatment of chemotherapy-induced nausea and vomiting; ProStrakan; Approved September 2008
Pulmonary/Respiratory Diseases
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Alvesco (ciclesonide); For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents; Nycomed; Approved January 2008
Orencia (abatacept); For the treatment of Juvenile Idiopathic Arthritis; Bristol-Myers Squibb; Approved April 2008
Trauma/Emergency Medicine
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