New Drug Approvals Archive - 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.

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

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.

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

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: Chronic 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

Xibrom (bromfenac) is an ophthalmic nonsteroidal antiinflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract extraction.