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 (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
 
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 (micafungin sodium) 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 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 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)
 
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
 

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