Hepatitis C Therapies
Chronic HCV Therapy Receives FDA Priority Classification
Published in Hepatitis Weekly, February 2nd, 1998
ICN Pharmaceuticals, Inc., New York, New York, was informed by its licensing partner Schering-Plough Corporation that Schering-Plough has received a letter from the U.S. Food and Drug Administration (FDA) on the status of the company's New Drug Application (NDA) for the combination use of INTRON A (interferon alfa-2b, recombinant for injection) and REBETOL (ribavirin USP capsules) for the treatment of chronic hepatitis C.
The letter confirmed the FDA's receipt of the NDA on December 5, 1997, and that the "priority" therapeutic classification has been assigned. In accordance with federal regulation (21 CPR 31.1O1) the FDA has 60 days from the date of receipt to...
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Source: Hepatitis Weekly (1998-02-02)
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