FDA Again Delays Nod For Novo Nordisk Long-Acting Insulin

Law360, New York (July 18, 2012, 6:53 PM EDT) -- The U.S. Food and Drug Administration has delayed for the second time a decision on whether to approve Danish pharmaceutical company Novo Nordisk A/S’s potential blockbuster diabetes treatment insulin degludec pending review by outside experts, the company announced Wednesday.

Degludec first was submitted for approval in September 2011, and the FDA originally informed Novo that it would decide on approval of the drug by the end of July. The regulator delayed its decision on June 8, saying it would decide on approval of the drug by the...
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.