We use cookies on this site to enable your digital experience. By continuing to use this site, you are agreeing to our cookie policy. close

FDA Takes Step Toward Allowing ANDAs For Zometa

Law360 (April 14, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has determined that Novartis AG’s bone cancer drug Zometa was not withdrawn from sale for reasons of safety or effectiveness, paving the way for generic-drug manufacturers to file abbreviated new drug applications.

The findings, which were published in the Federal Register on Tuesday, will allow the FDA to approve ANDAs for zoledronic acid lyophilized powder for injection, marketed under the name Zometa.

“FDA’s independent evaluation of relevant information has uncovered no information that would indicate this product was withdrawn for...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.