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FDA Expands Astellas' Mycamine Label

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Astellas Pharma, Inc. recently announced the receipt of US Food and Drug Administration (FDA) approval for the expanded use of Mycamine injection in pediatric patients four months and older.

Mycamine is now approved for the treatment of infants with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT).

The safety and efficacy of Mycamine in both adult and pediatric patients were evaluated in two randomized, double-blind and active controlled studies - one for the treatment of invasive candidiasis and candidemia, and the other for the prevention of Candida infections in patients undergoing HSCT. 479 patients (age – 3 days to 16 years) were given at least one dose of Mycamine in 11 separate studies.

As per the information provided by Astellas, the candida species form the third most common cause of pediatric health care associated bloodstream infection.

In Mar 2005, the FDA had approved Mycamine for the prevention of Candida infections in patients undergoing HSCT and the treatment of esophageal candidiasis. In Apr 2008, EU approval was received for the treatment of patients with invasive candidiasis, prevention of Candida infection in patients undergoing allogeneic HSCT. Additionally, for patients >=16 years of age the drug was approved for oesophageal candidiasis.

In 2012, Mycamine sales in the US were $104 million, up 6.4%.

Astellas carries a Zacks Rank #4 (Sell). Currently, companies like Santarus, Inc. , Jazz Pharmaceuticals (JAZZ - Free Report) and Salix Pharmaceuticals Ltd. look well positioned with a Zacks Rank #1 (Strong Buy).

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