Therapy (HCV)

Rebetol Supplemental NDA Submitted for Combination Therapy Use

Published in Hepatitis Weekly, January 8th, 2001

ICN Pharmaceuticals, Inc. (ICN), Costa Mesa, California, announced that Schering-Plough Corp. (SGP) submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Rebetol (ribavirin, USP) Capsules.

Rebetol is for separate use in combination with Intron A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy.

Rebetol is approved in the United States for this indication as a component of Rebetron Combination Therapy,...

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Source: Hepatitis Weekly (2001-01-08)

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