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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 Fujisawa Healthcare, Inc. - Treatment 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 contains mometasone furoate, a corticosteroid demonstrating potent antiinflammatory activity. Asmanex Twisthaler is indicated for the first-line maintenance treatment of asthma as preventive therapy in patients 12 years of age and older, and is also the only inhaled asthma controller therapy approved for once daily initiation and management of asthma in patients previously treated with bronchodilators alone or inhaled corticosteroids.

Asmanex Schering-Plough Corporation - Treatment for Asthma
 
March 31
Nexium IV (esomeprazole magnesium) Injection

Date of Approval: March 31, 2005

Company: AstraZeneca

Treatment for Gastroesophageal Reflux Disease

Nexium IV is an intravenous formulation of the prescription proton pump inhibitor Nexium. Nexium IV is approved as an intravenous infusion or injection for the short-term treatment (up to 10 days) of gastroesophageal reflux disease (GERD) patients, with a history of erosive esophagitis, who are unable to take capsules.

Nexium IV AstraZeneca - Treatment for Gastroesophageal Reflux Disease (GERD)
 

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