Pfizer Drug Conditionally Cleared
Pfizer (PFE) has received conditional approval from the Food and Drug Administration for a new fungal infection drug, but the company declined to say what the conditions are or how long it will take to meet those requirements.
The drug, called anidulafungin, is designed to fight fungal infections that affect the skin or mucous membrane but that also can enter the bloodstream and damage the heart. Pfizer initially asked the FDA to approve the drug for fungal infections of the esophagus.
The FDA was scheduled to act in late November, but the company didn't announce the agency's response. A Pfizer spokesman on Tuesday confirmed that his company received an "approvable letter" from the FDA on Nov. 25, indicating the agency wanted more information. He declined to comment on the requirements.
Anidulafungin is one of two anti-infectives that were in late-stage development at
Vicuron Pharmaceuticals when Pfizer
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