FDA Approves Hepatitis C Drug


WASHINGTON, DC-Officials from the Food and Drug Administration (FDA) approved a Shering-plough Corporation hepatitis C drug could be packaged and marketed alone for the first time.

Patients in need of ribavirin have previously had to purchase Shering's Rebetron kit, containing two drugs: ribavirin and interferon-A. The kit can cost $1,400 to $1,600 a month for some patients who only need ribavirin. Patient protest forced the agency to reexamine their marketing rules.

Today agency officials announced Schering could sell the drug in a separate package, under the name Rebetrol. Sales will begin this fall with no word from the manufacturer how much the prescription will cost. A Schering spokesperson did say the FDA approved the drug to be used with Schering's interferon brand, called Intron A. However, physicians do not have to prescribe the two drugs together now that they will not be packaged together.

Hepatitis C is a viral bloodborne disease that attacks the liver and can cause jaundice, fatigue, pain, and vomiting. It can lead to liver damage and cancer. There are an estimated four million Americans who have the virus.

Information from www.nytimes.com

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