Contraception

FDA extends Plan B emergency contraceptive PDUFA date

Published in Biotech Business Week, March 15th, 2004

Barr Pharmaceuticals, Inc., (BRL) and Women's Capital Corporation (WCC) said that the U.S. Food and Drug Administration (FDA) has extended the original 10-month Prescription Drug User Fee Act (PDUFA) deadline for completion of its review of the Plan B Supplemental New Drug Application (sNDA).

Barr and WCC are seeking approval to market the Plan B emergency contraceptive over-the-counter (OTC) without a prescription. The PDUFA extension will permit the FDA to complete its review of the application, including additional data on adolescent use that was submitted by Barr and WCC in support of the application.

Based on its ongoing dialogue with FDA, Barr...

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 Biotech Business Week

Source: Biotech Business Week (2004-03-15)

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