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Accentia BioPharmaceuticals, Inc.
U.S. FDA grants Accentia Biopharmaceuticals Fast Track status for SinuNase
May 8th, 2006
Accentia Biopharmaceuticals, Inc. (ABPI) has been notified that the U.S. Food and Drug Administration (FDA) granted Fast Track status to SinuNase, the company's intranasal Amphotericin B formulation. To the best of the company's knowledge, SinuNase is the first and only drug candidate for chronic sinusitis (CS) to receive Fast Track status from the FDA. With Fast Track status for SinuNase, Accentia is now eligible to submit a new drug license application (NDA) on a rolling basis, allowing the FDA to review sections of the NDA in advance of receiving Accentia's full submission, and permitting Accentia to apply for expedited review of its NDA. ...
Source: Biotech Week (2006-05-08)
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