India Approves Ribavirin Drug for Hepatitis Treatment, ICN Says

ICN Pharmaceuticals Inc. said Thursday that the government of India has approved its antiviral drug ribavirin for the treatment of acute hepatitis and several other ailments.

“We believe it is an important approval for the company because of the prevalence of hepatitis in India,” said Jack Scholl, an ICN spokesman.

ICN said the drugs controller of the Directorate Health Services of India gave the go-ahead for the company to market ribavirin under the trade name Virazole for the treatment of acute hepatitis as well as viral respiratory and herpes simplex infections.

Virazole is approved for sale in the United States only for the treatment of infants and young children hospitalized with severe respiratory tract infections. But the drug is sold in 36 other countries for the treatment of a variety of other viral infections, Scholl said.

Late last year, the Costa Mesa drug maker halted a lengthy effort to gain U.S. government approval to market ribavirin as a treatment for patients with early-stage AIDS symptoms. Only one country, Ireland, has approved ribavirin for treating pre-AIDS conditions. ICN has applied to market the drug for AIDS patients in a number of other countries, Scholl said.