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New Drug Approvals Archive - March 2005

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 (desloratadine and pseudoephedrine sulfate) is a once-daily antihistamine and decongestant for the relief of the symptoms of seasonal allergic rhinitis. Clarinex-D 24 Hour Schering-Plough Corporation - Treatment for Symptoms of Seasonal Allergic Rhinitis Clarinex-D 24 Hour (desloratadine and pseudoephedrine sulfate) FDA Approval History
March 16	Mycamine (micafungin sodium) for Injection Date of Approval: March 16, 2005 Company: Fujisawa Healthcare, Inc. Treatment for: Esophageal Candidiasis, Fungal Infection Prophylaxis, Candidemia Mycamine (micafungin sodium) is an echinocandin antifungal agent used for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, for the treatment of esophageal candidiasis and candidemia. Mycamine Approved for Candida Infections Mycamine (micafungin sodium) FDA Approval History
March 16	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. Symlin Amylin Pharmaceuticals, Inc. - Treatment for Diabetes in conjunction with insulin Symlin (pramlintide acetate) FDA Approval History
March 24	Xibrom (bromfenac) Ophthalmic Solution Date of Approval: March 24, 2005 Company: ISTA Pharmaceuticals, Inc. Treatment for: Postoperative Ocular Inflammation Xibrom (bromfenac) is an ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract extraction. Xibrom ISTA Pharmaceuticals, Inc. - Treatment for Ocular Inflammation Following Cataract Surgery Xibrom (bromfenac) FDA Approval History
March 29	Baraclude (entecavir) Tablets / Oral Solution Date of Approval: March 29, 2005 Company: Bristol-Myers Squibb Company Treatment for: Chronic Hepatitis B Baraclude (entecavir) is a nucleoside analogue oral antiviral therapy for the treatment of chronic hepatitis B in adults. Baraclude Bristol-Myers Squibb Company - Treatment for Chronic Hepatitis B Baraclude (entecavir) FDA Approval History
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 Asmanex (mometasone furoate) FDA Approval History
March 31	Nexium (esomeprazole) New Dosage Form Approved: March 31, 2005 Nexium IV Approved for Gastroesophageal Reflux Disease (GERD)
March 24	Xibrom (bromfenac) Ophthalmic Solution Date of Approval: March 24, 2005 Company: ISTA Pharmaceuticals, Inc. Treatment for: Postoperative Ocular Inflammation Xibrom (bromfenac) is an ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract extraction. Xibrom - ISTA Pharmaceuticals, Inc. - New Indication Approved Xibrom (bromfenac) FDA Approval History
October 1	Symlin (pramlintide acetate) New Dosage Form Approved: September 25, 2007 FDA Approves Symlin Pen-Injector Devices Offering Convenience and Accuracy for Symlin Use Symlin (pramlintide acetate) FDA Approval History
January 23	Mycamine (micafungin sodium) New Indication Approved: January 22, 2008 FDA Approves Additional Indication for Astellas' Mycamine Mycamine (micafungin sodium) FDA Approval History
February 4	Asmanex (mometasone furoate) Patient Population Altered: February 4, 2008 FDA Approves Asmanex Twisthaler (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11 Asmanex (mometasone furoate) FDA Approval History
October 18	Baraclude (entecavir) New Indication Approved: October 15, 2010 U.S. Food and Drug Administration Approves Baraclude (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease Baraclude (entecavir) FDA Approval History
June 24	Mycamine (micafungin sodium) Patient Population Altered: June 21, 2013 FDA Approves Pediatric Indication for Astellas' Mycamine (micafungin sodium) for Injection Mycamine (micafungin sodium) FDA Approval History

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