Generic Drugs

Teva gets U.S. FDA approval of ANDA for ondansetron injection used to treat nausea, vomiting

Published in Surgery Litigation and Law Weekly, December 29th, 2006

Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food and Drug Administration has granted final approval for the company's abbreviated new drug applications (ANDAs) for ondansetron injection USP, 2 mg/mL, packaged in 4 mg/2 mL single-dose vials, 2 mg/mL, packaged in 40 mg/20 mL multiple-dose vials and 0.64 mg/mL packaged in 32 mg/50 mL bags.

Shipment of these products will begin immediately following a 2005 patent litigation settlement with GlaxoSmithKline.

Teva's ondansetron injection products are the AP-rated generic equivalent of GlaxoSmithKline's antiemetic Zofran injection.

The product, in the three...

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 Surgery Litigation and Law Weekly

Source: Surgery Litigation and Law Weekly (2006-12-29)

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