|By PR Newswire||
|April 16, 2014 01:23 PM EDT||
NORTHBROOK, Ill., April 16, 2014 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that it has reached an agreement with the U.S. Department of Justice to resolve civil claims regarding the marketing of MYCAMINE® (micafungin sodium) for injection. Under the agreement, Astellas will pay $7.3 million to the settling parties.
The Department of Justice had investigated Astellas for alleged off-label promotion of MYCAMINE for pediatric use, a claim the company has consistently denied. MYCAMINE is an injectable drug used to treat or prevent certain serious fungal infections and, at the time of the investigation, had not yet been approved for pediatric use in the United States. MYCAMINE received approval by the U.S. Food and Drug Administration (FDA) in June, 2013 for use in children four months and older.
Said Astellas Pharma US, Inc. CEO Masao Yoshida, "Astellas cooperated fully with the U.S. Government's review of this matter, and we are pleased to have reached a resolution." He continued, "In keeping with our corporate commitment to conduct business with a high sense of ethics, our policy has always been to promote our products in accordance with FDA regulations."
Indications and Usage:
MYCAMINE is indicated in adults and pediatric patients four months and older for:
- Treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses.
- MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections
- Treatment of patients with esophageal candidiasis
- Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation
- NOTE: The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.
Important Safety Information for MYCAMINE® (micafungin sodium) for Injection
MYCAMINE is contraindicated in patients with known hypersensitivity to micafungin sodium, any component of MYCAMINE, or other echinocandins.
Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE. In these cases, MYCAMINE should be discontinued and administer appropriate treatment.
Elevations in BUN and creatinine, isolated cases of clinically significant hepatic dysfunction, hepatitis, hepatic failure, renal dysfunction, acute renal failure, hemolysis, or hemolytic anemia have occurred in some patients who have received MYCAMINE. Patients who develop these conditions, or abnormal liver or renal function tests, should be monitored closely for worsening function and evaluated for risk/benefit of continuing MYCAMINE therapy.
In clinical trials, possible histamine-mediated symptoms have been reported with MYCAMINE (including rash, pruritus, facial swelling, and vasodilatation).
In clinical trials, the most common treatment-emergent adverse reactions in adults for all indications included diarrhea, nausea, vomiting, pyrexia, thrombocytopenia, and headache. The most common treatment-emergent adverse reactions observed in pediatric patients four months and older included vomiting, diarrhea, pyrexia, nausea, abdominal pain and thrombocytopenia.
Please see complete Prescribing Information for MYCAMINE.
About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.us.
SOURCE Astellas Pharma US, Inc.
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