New Drug Approvals Archive
New Drug Approvals: June 2005
| June 3 | Revatio (sildenafil citrate) Tablets Company: Pfizer Inc. Treatment for Pulmonary Arterial Hypertension Revatio Pfizer Inc. - Treatment for Pulmonary Arterial Hypertension |
| June 3 | Glumetza (metformin extended release) Tablets Date of Approval: December 31, 1969 Company: Biovail Corporation/Depomed, Inc. Treatment for Diabetes Mellitus Type II Glumetza is a once-daily, extended-release formulation of metformin hydrochloride which may offer potential advantages such as less frequent dosing and fewer side effects. Glumetza is indicated for the treatment of Type 2 diabetes. Glumetza Biovail Corporation/Depomed, Inc. - Treatment for Type 2 Diabetes |
| June 10 | Zmax () for Oral Suspension Company: Pfizer Inc. Treatment for Sinusitis and Pneumonia Zmax Pfizer Inc. - Treatment for Sinusitis and Pneumonia |
| June 10 | Adacel (diphtheria, pertussis acellular, and tetanus vaccine) Date of Approval: June 10, 2005 Company: Aventis Pasteur Limited Treatment for Tetanus Prophylaxis, Diphtheria Prophylaxis, Pertussis Prophylaxis Adacel is indicated as a booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 11 through 64 years of age. Adacel is the first vaccine approved as a pertussis booster for adults. Adacel Aventis Pasteur Limited - Treatment for Prevention of Tetanus, Diphtheria & Pertussis |
| June 15 | Tygacil (tigecycline) Injection Company: Wyeth Pharmaceuticals Treatment for Complicated Skin and Intra-abdominal Infections 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 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 is a non-peptidic protease inhibitor that works by inhibiting protease, an enzyme needed to complete the HIV replication process. Aptivus, co-administered with 200 mg of ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors. Aptivus Boehringer Ingelheim - Treatment for HIV Infection |
| June 23 | Synera (lidocaine and tetracaine) Topical Patch - formerly S-Caine Patch Company: ZARS, Inc. Treatment for Topical Anesthesia Synera ZARS, Inc. - Treatment for Topical Anesthesia |
| 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 30 | Metrogel () Topical Gel 1% Company: Dow Pharmaceutical Sciences Treatment for Rosacea Metrogel Dow Pharmaceutical Sciences - Treatment for Rosacea |
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