FDAnews Drug Daily Bulletin

ACCENTIA'S SINUNASE GETS FAST-TRACK STATUS

April 21, 2006
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The FDA has granted fast-track status to Accentia's drug SinuNase, a treatment for chronic sinusitis (CS).

SinuNase (Amphotericin B deoxycholate, or AMB) is the first drug candidate for CS to receive FDA fast-track status, the company said. Accentia is now eligible to submit a new drug application (NDA) to the FDA on a rolling basis, which will allow the agency to review sections of the application prior to receiving the complete submission and will permit the company to apply for an expedited review of its NDA.

CS, also known as chronic rhinosinusitis (CRS), is an inflammation of the nasal and sinus mucosa that can persist for more than three months at a time, Accentia said. The condition affects nearly 31 million Americans.