Generic Versions of Hepatitis C Drug Approved
FDA Approves 2 Generic Forms of Ribavirin for Hepatitis C Treatment
April 8, 2004 -- The FDA has approved two new generic versions
of a drug that's a mainstay of hepatitis C treatment.
Yesterday, the FDA approved generic versions of the drug
ribavirin, which until now has been sold under the brand name Rebetol by
Schering-Plough and Roche.
Ribavirin is typically used in combination with interferon for
the treatment of chronic hepatitis C. Experts say the approval of generic
versions will likely reduce the cost of chronic hepatitis C treatment, which
currently costs up to $25,000 per year.
Infection with the hepatitis C virus is a leading cause of
liver disease in the U.S. and the No. 1 cause of liver transplants. It affects
about 4 million Americans. Hepatitis C infection can lead to cirrhosis and
liver cancer. More than 30,000 new cases are diagnosed each year.
The hepatitis C virus is most commonly transmitted via contact
with contaminated blood through sharing needles or other medical equipment. It
may also be transmitted through sexual contact with an infected individual.
Generic Hepatitis C Drugs Approved
Sandoz Inc., a subsidiary of Swiss drug maker Novartis, and
Three Rivers Pharmaceuticals both received approval from the FDA to market
their copycat versions of ribavirin for the treatment of chronic hepatitis
Three Rivers Pharmaceuticals plans to sell its drug under the
name Ribasphere, and Sandoz will sell its version under the name Ribavirin
Although the companies did not disclose how much the new
generic versions would cost, generic drugs usually cost much less than their
brand-name counterparts. In addition, the introduction of generic versions of a
drug usually drives down the cost of the name-brand version.