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FDA rejects priority review for Schering-Plough
PISCATAWAY, N.J., Feb 10 (Reuters) - The U.S. Food and Drug
Administration has refused to grant priority review to
Schering-Plough Corp.'s (NYSE:SGP - news) PEG-INTRON treatment for
hepatitis C, Enzon Inc. (NasdaqNM:ENZN - news) said on Thursday.
The treatment was placed on standard review, which takes longer,
PEG-INTRON is a modified form of Schering-Plough's INTRON A that
uses proprietary technology developed by Enzon.
Schering-Plough submitted its Biologics License Application to
the FDA on Dec. 23.
Under the Prescription Drug Users Fee Act, the FDA should act on
Schering-Plough's BLA within 12 months from the date of receipt.
Priority review would have taken six months.
Enzon shares were off 5 to 48-7/8 and Schering-Plough shares
were off 2-1/4 to 43-1/16, both in morning trade on the New York
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