New Drug Approvals Archive
New Drug Approvals: March 2005
| March 3 | Clarinex-D 24 Hour (desloratadine and pseudoephedrine sulfate) ER Tablets Date of Approval: March 3, 2005 Company: Schering-Plough Corporation Treatment for Allergic Rhinitis Clarinex-D 24 Hour uses a Gel Control system providing once-daily 24-hour efficacy for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older. Clarinex-D 24 Hour Schering-Plough Corporation - Treatment for Symptoms of Seasonal Allergic Rhinitis |
| March 11 | Xopenex HFA () Inhalation Aerosol Company: Sepracor Inc. Treatment for Bronchospasm Xopenex HFA Sepracor Inc. - Treatment for Bronchospasm |
| March 16 | Symlin () Injection Company: Amylin Pharmaceuticals, Inc. Treatment for Diabetes in conjunction with insulin Symlin Amylin Pharmaceuticals, Inc. - Treatment for Diabetes in conjunction with insulin |
| March 16 | Mycamine (micafungin sodium) for Injection Date of Approval: March 16, 2005 Company: Fujisawa Healthcare, Inc. Treatment for Esophageal Candidiasis, Fungal Infection Prophylaxis Mycamine is an echinocandin antifungal agent used for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation and the treatment of esophageal candidiasis. Mycamine Approved for Candida Infections |
| March 24 | Xibrom () Ophthalmic Solution Company: ISTA Pharmaceuticals, Inc. Treatment for Ocular Inflammation Following Cataract Surgery and Ocular Pain Following Cataract Surgery Xibrom ISTA Pharmaceuticals, Inc. - Treatment for Ocular Inflammation Following Cataract Surgery |
| March 24 | Boniva (ibandronate sodium) Tablets Date of Approval: May 16, 2003 Company: Hoffmann-La Roche Inc Treatment for Osteoporosis, Prevention of Osteoporosis Boniva is a biphosphonate drug which helps increase bone mass. Boniva is used to treat or prevent osteoporosis in women after menopause. Boniva Roche and GlaxoSmithKline (GSK) - Treatment for Postmenopausal Osteoporosis |
| March 29 | Baraclude (entecavir) Tablets / Oral Solution Date of Approval: March 29, 2005 Company: Bristol-Myers Squibb Company Treatment for Chronic Hepatitis B Baraclude is a nucleoside analogue oral antiviral therapy that works by interfering with viral reproduction. Baraclude is indicated for the treatment of chronic hepatitis B in adults. Baraclude Bristol-Myers Squibb Company - Treatment for Chronic Hepatitis B |
| March 30 | Asmanex (mometasone furoate) Inhalation Powder Date of Approval: March 30, 2005 Company: Schering-Plough Corporation Treatment for Asthma Asmanex Twisthaler (mometasone furoate) is an inhaled corticosteroid for the treatment of asthma. FDA Approves Asmanex Twisthaler for Asthma |
| March 31 | Nexium (esomeprazole)
New Dosage Form Approved: March 31, 2005 Nexium IV Approved for Gastroesophageal Reflux Disease (GERD) |
New Drug Approvals Archive
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