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Bristol Seeking Two NDAs For UFT Combos In Response To Rebetron Debate

Executive Summary

Bristol-Myers Squibb's submission of two separate NDAs for the combination use of UFT and leucovorin appears to be a new filing and approval strategy for the development of bundled multi-ingredient products.

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Ribavirin ANDAs Await ICN Petition; FDA Generic Rule Takes Effect

The delay in approval for generic versions of Schering-Plough's Rebetol (ribavirin) illustrates one limitation of FDA's revised Waxman/Hatch regulations

Ribavirin ANDAs Await ICN Petition; FDA Generic Rule Takes Effect

The delay in approval for generic versions of Schering-Plough's Rebetol (ribavirin) illustrates one limitation of FDA's revised Waxman/Hatch regulations

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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