Sandoz Inc., a Novartis company, announced it is launching generic Rebetol (Ribavirin), which used in combination with interferon is indicated for the treatment of hepatitis C.
"As one of the first providers of Ribavirin, we are committed to delivering value to patients and to our customers by offering a lower-cost alternative for the treatment of hepatitis C," said John Sedor, president and chief executive officer of Sandoz in North America. "People with hepatitis C who need this drug therapy will now be able to obtain it more readily and receive excellent patient support."
The U.S. Food and Drug Administration (FDA) awarded Sandoz shared exclusivity for Ribavirin in approving its Abbreviated New Drug Application (ANDA) to manufacture and market the product. Sandoz will market Ribavirin in 200 mg capsules in multiple-count bottles. The product will be manufactured at a Sandoz facility in Colorado using state-of-the-art isolation suite technology.
Hepatitis C virus is one of the leading causes of chronic liver disease in the U.S., according to the National Institutes of Health. Hepatitis C affects more than four million Americans, the majority of whom are still undiagnosed and untreated.
According to IMS data, 2003 sales for Rebetol reached $645 million. Rebetol is a registered trademark of Schering-Plough.