Schering-Plough seeking approval in Japan
- Schering-Plough Submits New Drug Application (J-NDA) in Japan for PEG-INTRON(R) and REBETOL(R) Combination Therapy for Hepatitis C
Wednesday April 21, 10:00 pm ET
KENILWORTH, N.J., April 21 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today announced that Schering-Plough K.K., the company's subsidiary in Japan, has submitted a New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for PEG-INTRON� (peginterferon alfa-2b) Powder for Injection for use in combination with REBETOL� (ribavirin) Capsules for the treatment of chronic hepatitis C. The MHLW will provide a priority review of the application. If approved, PEG-INTRON and REBETOL will be the first and only pegylated interferon-based combination therapy approved in Japan for treating chronic hepatitis C.
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