Schering-Plough PEG-Intron
Executive Summary
Schering-Plough plans fall launch of PEG-Intron (peginterferon alfa-2b) in combination with Rebetol (ribavirin) for treatment of chronic hepatitis C following Aug. 7 supplemental approval. Rebetol was approved July 26 as a separate product to be used with Intron A and was previously approved as part of the ribavirin/Intron A combination therapy Rebetron (1"The Pink Sheet" July 30, p. 19)
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Schering Rebetol
Hepatitis C treatment Rebetol (ribavirin) approved July 26 as a separate product to be used in combination with Intron A, Schering-Plough says. Rebetol is approved for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with, or relapsed on, alpha interferon. Ribavirin/Intron A was first approved as a combination therapy in 1998 as Rebetron; patient advocacy groups complained that bundling the products denies patients the opportunity to try to use cheaper interferon brands in combination with ribavirin (1"The Pink Sheet" Aug. 30, 1999, p. 7). Schering plans to launch the drug this fall. As is the case with most Schering products, FDA's recent inspection reports on the company include observations about the production of ribavirin
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