New Drug Approvals Archive
New Drug Approvals: June 2005
| June 3 | Revatio (sildenafil citrate) Tablets and Injection 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 |
| 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 |
| 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 |
| June 16 | Levemir (insulin detemir ) Injection Date of Approval: June 16, 2005 Company: Novo Nordisk Inc. Treatment for: Diabetes Mellitus Type I, Diabetes Mellitus Type II 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) |
| 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 |
| 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 |
| 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 |
| June 24 | Aptivus (tipranavir)
New Dosage Form Approved: June 23, 2008 New Aptivus (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients |
| 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 |
| 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 |
New Drug Approvals Archive
2009: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Feb | Jul | Aug | Oct | Nov | Dec
