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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (650)	8/19/1998 7:29:00 AM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

Schering-Plough Reports Priority Review Status Assigned to sNDA for Use of REBETRON(TM) Combination Therapy in Treatment-Naive Hepatitis C Patients Wednesday August 19, 4:33 am Eastern Time Company Press Release SOURCE: Schering-Plough Corporation MADISON, N.J., Aug. 17 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP - news) today reported that the U.S. Food and Drug Administration (FDA) has assigned priority review status to the company's supplemental New Drug Application (sNDA) for REBETRON(TM) Combination Therapy for the treatment of chronic hepatitis C in treatment-naive patients. FDA has notified Schering-Plough that it received the sNDA on June 17 and that the application was accepted for filing with priority review status on Aug. 15. Priority review status provides for FDA action within 180 days from the date of filing. The sNDA seeks clearance to market REBETRON Combination Therapy containing REBETOL(R) (ribavirin, USP) Capsules and INTRON(R) A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon therapy. Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with ICN Pharmaceuticals, Inc. (NYSE: ICN - news) of Costa Mesa, Calif. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide. SOURCE: Schering-Plough Corporation biz.yahoo.com