US FDA grants priority status to S-P's 'Rebetol'

08 April 2003 22:10  [Source: ICIS news]

HOUSTON (CNI)--US drug maker Schering-Plough (S-P) said Tuesday the US Food and Drug Administration (FDA) has granted priority review status to its new drug application (NDA) for Rebetol for treating paediatric hepatitis C.

Priority review status is granted to drugs that, if approved, address unmet medical needs, S-P said.

S-P's application seeks FDA approval of Rebetol for use in combination with Intron A for the treatment of chronic hepatitis C in patients three years and older.

The company said that less than 200 000 children in the US are infected with the hepatitis C virus (HCV).

Said Robert Spiegel, senior vice president of medical affairs and chief medical officer, Schering-Plough Research Institute: "FDA approval of Rebetol for use with Intron L would represent the first and only therapy approved in the US for treating hepatitis C in the paediatric population."

Shares of the Kenilworth, New Jersey-based company were off 2% or 30 cents to $17.20 in trading on the New York Stock Exchange.

By: Mike Sheridan
+1 713 525 2653

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