FDA rejects priority review for PEG-Intron


 What is Hepatitis

 How is it Transmitted

 Long Term Prognosis

 Complications of HCV

 Liver Biopsy

 Treatment Info (Interferon, Herbal, etc)

 Lab Tests (PCR, Genotype,etc.)

 Nutrition & Alternative Info

 Patient Information (Support Groups, Doctor Listing, etc)

 Related Webpages

 Transplant Info

 HCV Webrings

 My guestbookbook

 Site Awards

 FAQ & Disclaimers

FDA rejects priority review for Schering-Plough drug
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, Enzon said.

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 Stock Exchange.

Home | What is HCV | Transmission | Future | Complications | Biopsy | Treatment | Lab | Nutrition | Patient | Links | Transplant | Webrings | guestbookbook | Awards | FAQ |