Navigation Links
FDA Approves Additional Indication for Astellas' MYCAMINE(R)

DEERFIELD, Ill., Jan. 23 /PRNewswire/ -- Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved their Supplemental New Drug Application (sNDA) seeking approval for the use of MYCAMINE(R) (micafungin sodium) for Injection in the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. MYCAMINE was approved in 2005 for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.


"The FDA's approval of this sNDA further confirms the safety and efficacy profile of MYCAMINE and its importance in the treatment of candidemia and other Candida infections," said Yoshihiko Hatanaka, President and Chief Executive Officer, Astellas Pharma US, Inc. "The approval of this additional indication is another step toward fulfilling our mission to provide innovative treatments such as MYCAMINE to help patients with significant medical needs."

About Candidemia

Candidemia is a fungal infection that occurs when Candida species enter the blood, causing bloodstream infection with the potential to spread to another part of the body.

According to the Center for Disease Control (CDC), candidemia is the fourth most common bloodstream infection among hospitalized patients in the United States. A survey conducted at CDC found that candidemia occurs in 8 of every 100,000 persons per year. Persons at high risk for candidemia include surgical patients, and those whose immune systems are deficient.


MYCAMINE is a member of a newer class of antifungal agents, the echinocandins. MYCAMINE inhibits an enzyme essential for fungal cell-wall synthesis and is fungicidal (lethal) for Candida.

MYCAMINE is approved for the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses; for the treatment of patients with Esophageal Candidiasis and the prophylaxis of Candida Infections in patients undergoing Hematopoietic Stem Cell Transplantation. The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established. MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections.

MYCAMINE can be used concomitantly with a number of other drugs, including the HIV protease inhibitor ritonavir and the transplant medications cyclosporine and tacrolimus with no alteration in the pharmacokinetics of MYCAMINE. Patients should be monitored for sirolimus, nifedipine or itraconazole toxicity if receiving these drugs in combination with MYCAMINE and their dosage reduced, if necessary.

MYCAMINE is available in two sizes, 50mg vial and 100mg vial, offering clinicians convenience of use in the administration of the drug, while reducing waste in the hospital setting.

Important Safety Information

MYCAMINE is contraindicated in patients with hypersensitivity to any component of this product or other echinocandins.

Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE.

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 for worsening function and evaluated for risk/benefit of continuing MYCAMINE therapy.

Adverse events with MYCAMINE included histamine-mediated symptoms (including rash, pruritus, facial swelling, and vasodilatation). The most common treatment-emergent adverse events include diarrhea, nausea, vomiting, pyrexia, hypokalemia, thrombocytopenia and headache.

About Astellas Pharma US, Inc.

Astellas Pharma US, Inc., located in Deerfield, 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 by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of immunology, urology, anti-infectives, cardiovascular and dermatology. For more information about Astellas Pharma US, Inc., please visit our website at

SOURCE Astellas Pharma Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
(Date:10/13/2015)... ... , ... Symposium Chairman, Dr. Rod J. Rohrich is pleased to announce that ... March 2nd and 3rd, 2016. The annual meeting, along with the Dallas Rhinoplasty ... around the world. , Key topics at this year's event will include discussions on ...
(Date:10/13/2015)... ... October 13, 2015 , ... Relay (, a ... announced today a significant contract that will provide its award-winning private messaging solution ... on the growing success of its Relay program, IBX Wire™, which now has ...
(Date:10/13/2015)... ... October 13, 2015 , ... NavaFit Inc. today announced the launch of ... train with, participate in local fitness & sporting events, and stay motivated. ... high medical costs drive us to get more serious about fitness and wellness, individuals ...
(Date:10/13/2015)... Boston, MA (PRWEB) , ... October 13, 2015 , ... ... mortar of the body, including muscle, bone, and blood. But how much protein does ... more complicated than it might seem, according to the October 2015 issue of ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... Scientists in ... tissue biopsy in 18 patients with or without mesothelioma. Surviving Mesothelioma has just posted ... , The doctors from PhenoPath Laboratories in Seattle and the University of British Columbia ...
Breaking Medicine News(10 mins):
(Date:10/13/2015)... , Oct. 13, 2015  Data Science Automation (DSA), ... opening of a new branch office in the ... DSA,s presence in Europe . The decision ... increasing demand for local support of customers in the medical ... Ph.D., DSA,s UK Branch Manager. "We have had tremendous success ...
(Date:10/13/2015)... -- SeraCare Life Sciences, a leading partner to global in ... medicine business unit has launched its second product in ... (NGS)-based tumor profiling assays.  The Seraseq TM Solid ... mutations in key oncogenes and tumor suppressor genes as ... is offered at five additional allele frequencies. ...
(Date:10/13/2015)... , Oct. 13, 2015  Graduate students across ... and medical research, will soon have the opportunity ... care – the drug discovery and development process. ... has collaborated with 10 leaders from academic institutions ... Medicines: The Process of Drug Development."  Lilly will ...
Breaking Medicine Technology: