Mycamine
Generic name: micafungin sodium
Treatment for: Esophageal Candidiasis, Fungal Infection Prophylaxis, Candidemia
Fujisawa Healthcare, Inc. Submits NDA For Mycamine For Treatment Of Esophageal Candidiasis
Deerfield, Ill., April 27, 2004-- Fujisawa Healthcare, Inc. (Fujisawa) announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for their investigational antifungal product to be marketed in the U.S. under the name Mycamine (micafungin sodium). With the submission of the NDA, Fujisawa seeks approval of micafungin for the treatment of esophageal candidiasis.
Micafungin is a member of a new class of antifungal agents, the echinocandins, which inhibit cell-wall synthesis. The novel mechanism of action of echinocandins specifically targets the wall of fungal cells to treat the infection.
About Esophageal Candidiasis
Esophageal candidiasis is a fungal infection located deep below the throat. It is most commonly seen in immuno-compromised patients. Approximately 10% of the U.S. AIDS population will have at least one episode of esophageal candidiasis. Symptoms of esophageal candidiasis can include chest pains and difficulty swallowing. Treating the presence of candidiasis in the esophagus, before it moves past the gastrointestinal tract, is key in arresting the progress of the fungus before it reaches more difficult to treat areas such as the lungs, bloodstream and kidney.
About Fujisawa Healthcare, Inc.
Fujisawa Healthcare, Inc., headquartered in Deerfield, Ill., develops, manufactures, and markets proprietary pharmaceutical products in the United States and abroad. Fujisawa Healthcare, Inc. is a subsidiary of Fujisawa Pharmaceutical Co., Ltd. based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its international operations in North America, Europe, and Asia. Fujisawa Healthcare, Inc. established its presence in the anti-fungal market with the launch of AmBisome (liposomal amphotericin B) in 1997.
Posted: April 2004
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Mycamine (micafungin sodium) FDA Approval History
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