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New Drug Approvals Archive - June 2005

June 2005

June 3	Revatio (sildenafil citrate) Date of Approval: June 3, 2005 Company: Pfizer Inc. Treatment for: Pulmonary Hypertension Revatio (sildenafil) is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension. Revatio Pfizer Inc. - Treatment for Pulmonary Arterial Hypertension Revatio (sildenafil citrate) FDA Approval History
June 3	Glumetza (metformin extended release) Tablets Date of Approval: June 3, 2005 Company: Biovail Corporation/Depomed, Inc. Treatment for: Diabetes Type 2 Glumetza (metformin extended-release) is a once-daily oral antihyperglycemic formulation indicated for the treatment of type 2 diabetes. FDA Approves Glumetza for Type 2 Diabetes Glumetza (metformin extended release) FDA Approval History
June 10	Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)) Date of Approval: June 10, 2005 Company: Aventis Pasteur Limited Treatment for: Tetanus Prophylaxis, Diphtheria Prophylaxis, Pertussis Prophylaxis Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)) is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age. Adacel Aventis Pasteur Limited - Treatment for Prevention of Tetanus, Diphtheria & Pertussis Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)) FDA Approval History
June 15	Tygacil (tigecycline) Injection Date of Approval: June 15, 2005 Company: Wyeth Pharmaceuticals Treatment for: Skin and Structure Infection, Intraabdominal Infection, Pneumonia Tygacil (tigecycline) is a glycylcycline antibacterial indicated for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired bacterial pneumonia in adults. Tygacil Wyeth Pharmaceuticals - Treatment for Complicated Skin and Intra-abdominal Infections Tygacil (tigecycline) FDA Approval History
June 16	Levemir (insulin detemir ) Injection Date of Approval: June 16, 2005 Company: Novo Nordisk Inc. Treatment for: Diabetes Type 1, Diabetes Type 2 Levemir (insulin detemir) is a novel, long- acting form of insulin that provides up to a 24-hour duration of action for the treatment of diabetes mellitus (type 1 and type 2). Levemir Novo Nordisk Inc. - Treatment for Diabetes Mellitus (Type 1 and Type 2) Levemir (insulin detemir ) FDA Approval History
June 22	Aptivus (tipranavir) Capsules Date of Approval: June 22, 2005 Company: Boehringer Ingelheim Treatment for: HIV Infection Aptivus (tipranavir) is a non-peptidic protease inhibitor which is co-administered with ritonavir for the treatment of HIV Infection. FDA Approves Aptivus for HIV Infection Aptivus (tipranavir) FDA Approval History
June 23	Synera (lidocaine and tetracaine) Topical Patch - formerly S-Caine Patch Date of Approval: June 23, 2005 Company: ZARS, Inc. Treatment for: Local Anesthesia Synera (lidocaine and tetracaine) is a local anesthetic patch indicated for use on intact skin to provide local dermal analgesia before certain medical procedures Synera ZARS, Inc. - Treatment for Topical Anesthesia Synera (lidocaine and tetracaine) FDA Approval History
June 23	BiDil (isosorbide dinitrate and hydralazine) Tablets Date of Approval: June 23, 2005 Company: NitroMed, Inc. Treatment for: Congestive Heart Failure BiDil is a fixed-dose combination of isosorbide dinitrate (a vasodilator) and hydralazine hydrochloride (an arterial dilator) indicated for the treatment of heart failure in black patients. BiDil NitroMed, Inc. - Treatment for Heart Failure in Black Patients BiDil (isosorbide dinitrate and hydralazine) FDA Approval History
June 22	Aptivus (tipranavir) Capsules Date of Approval: June 22, 2005 Company: Boehringer Ingelheim Treatment for: HIV Infection Aptivus (tipranavir) is a non-peptidic protease inhibitor which is co-administered with ritonavir for the treatment of HIV Infection. Aptivus (tipranavir) Capsules Granted Full Approval by the U.S. FDA Aptivus (tipranavir) FDA Approval History
January 2	Glumetza (metformin extended release) New Dosage Form Approved: December 4, 2007 Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza Glumetza (metformin extended release) FDA Approval History
June 24	Aptivus (tipranavir) New Dosage Form Approved: June 23, 2008 New Aptivus (tipranavir) Oral Solution Approved forTreatment-Experienced Pediatric and Adolescent HIV Patients Aptivus (tipranavir) FDA Approval History
March 24	Tygacil (tigecycline) New Indication Approved: March 20, 2009 FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia Tygacil (tigecycline) FDA Approval History
November 20	Revatio (sildenafil citrate) New Dosage Form Approved: November 18, 2009 FDA Approves Intravenous Formulation Of Pfizer's Revatio (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension Revatio (sildenafil citrate) FDA Approval History
April 2	Levemir (insulin detemir ) Labeling Revision Approved: March 29, 2012 FDA Approves Levemir Pregnancy Category Change for Women with Diabetes Levemir (insulin detemir ) FDA Approval History
May 22	Levemir (insulin detemir ) Patient Population Altered: May 18, 2012 FDA Approves Levemir for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes Levemir (insulin detemir ) FDA Approval History

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