New Drug Approvals Archive - March 2005
See also: New Indications and Dosage Forms for March 2005
March 2005
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 (desloratadine and pseudoephedrine sulfate) is a once-daily antihistamine and decongestant for the relief of the symptoms of seasonal allergic rhinitis.
Mycamine (micafungin sodium) for Injection
Date of Approval: March 16, 2005
Company: Astellas Pharma Inc.
Treatment for: Esophageal Candidiasis, Fungal Infection Prophylaxis, Candidemia
Mycamine (micafungin sodium) is an echinocandin antifungal agent indicated for the treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses, esophageal candidiasis, and for the prevention of candida Infections in patients undergoing Hematopoietic Stem Cell Transplantation (HSCT).
Symlin (pramlintide acetate) Injection
Date of Approval: March 16, 2005
Company: Amylin Pharmaceuticals, Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2
Symlin (pramlintide acetate) is an antihyperglycemic drug for use in patients with diabetes treated with insulin.
Xibrom (bromfenac) Ophthalmic Solution
Date of Approval: March 24, 2005
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation
Marketing Status: Discontinued
Xibrom (bromfenac) is an ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract extraction.
Baraclude (entecavir) Tablets / Oral Solution
Date of Approval: March 29, 2005
Company: Bristol-Myers Squibb Company
Treatment for: Hepatitis B
Baraclude (entecavir) is a nucleoside analogue oral antiviral therapy for the treatment of chronic hepatitis B in adults.
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.
Xibrom (bromfenac) Ophthalmic Solution
Date of Approval: March 24, 2005
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation
Marketing Status: Discontinued
Xibrom (bromfenac) is an ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract extraction.
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