New Drug Approvals Archive - 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.

• Mycamine Approved for Candida Infections
• Mycamine (micafungin sodium) FDA Approval History

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

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

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

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

Nexium (esomeprazole)

New Dosage Form Approved: March 31, 2005

• Nexium IV Approved for Gastroesophageal Reflux Disease (GERD)

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

Symlin (pramlintide acetate)

New Dosage Form Approved: September 25, 2007

• FDA Approves Symlin Pen-Injector Devices Offering Convenience andAccuracy for Symlin Use
• Symlin (pramlintide acetate) FDA Approval History

Mycamine (micafungin sodium)

New Indication Approved: January 22, 2008

• FDA Approves Additional Indication for Astellas' Mycamine
• Mycamine (micafungin sodium) FDA Approval History

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

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

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