Hepatitis C Virus

FDA issues approvable letter for ribavirin capsules

Published in Medical Letter on the CDC and FDA, March 28th, 2004

Par Pharmaceutical, Inc., the principal subsidiary of Pharmaceutical Resources, Inc. (PRX), announced that its marketing partner, Three Rivers Pharmaceuticals, has received an approvable letter from the U.S. Food and Drug Administration (FDA) for ribavirin 200-mg capsules.

The FDA has completed its review of Three Rivers' Abbreviated New Drug Application (ANDA) for ribavirin and has concluded that the application is approvable. Final approval is subject only to resolution of certain regulatory issues involving final product labeling.

Ribavirin, a synthetic nucleoside analogue with antiviral activity, is indicated for the treatment of hepatitis C, a...

Want to see the full article?

Purchase this article for only $3.00

We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.

Welcome to NewsRx!

Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA

Source: Medical Letter on the CDC and FDA (2004-03-28)

NewsRx is Social

Top Medical Newsletters

Awards

Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005

Facts & Stats

NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.

Google 2010 PageRank: #2 Among Top Health News and Media Publications
Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry