New Drug Approvals Archive

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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 (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 (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 (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 (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 (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.

Asmanex (mometasone furoate) FDA Approval History

March 31

Nexium (esomeprazole)

New Dosage Form Approved: March 31, 2005

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 (bromfenac) FDA Approval History

October 1

Symlin (pramlintide acetate)

New Dosage Form Approved: September 25, 2007

Symlin (pramlintide acetate) FDA Approval History

January 23

Mycamine (micafungin sodium)

New Indication Approved: January 22, 2008

Mycamine (micafungin sodium) FDA Approval History

February 4

Asmanex (mometasone furoate)

Patient Population Altered: February 4, 2008

Asmanex (mometasone furoate) FDA Approval History

October 18

Baraclude (entecavir)

New Indication Approved: October 15, 2010

Baraclude (entecavir) FDA Approval History

June 24

Mycamine (micafungin sodium)

Patient Population Altered: June 21, 2013

Mycamine (micafungin sodium) FDA Approval History

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