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Article: FDA approves new labeling for PEG-Intron for use with REBETOL.
- Article from:
- M2 Presswire
- Article date:
- August 8, 2001
CopyrightCOPYRIGHT 2001 Normans Media Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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M2 PRESSWIRE-8 August 2001-US FDA: FDA approves new labeling for PEG-Intron for use with REBETOL (C)1994-2001 M2 COMMUNICATIONS LTD
RDATE:08082001
FDA today approved a supplemental biologics application for PEG-Intron (peginterferon alfa-2b), an injectable product approved to treat patients with chronic hepatitis C infections, to be used in combination with REBETOL capsules (ribavirin).
PEG-Intron is a longer acting form of interferon than Intron A, (a previously approved form of interferon), and requires only one injection per week for one year compared to three per week for Intron A.
In January 2001, FDA approved PEG-Intron alone ...