Spectrum Pharma Investors Sue Over Rejected FDA Advice

By Melissa Daniels (February 23, 2017, 7:58 PM EST) -- Officers and directors at Spectrum Pharmaceuticals Inc. were hit with a shareholder derivative action in Delaware federal court on Thursday alleging they harmed investors and the company with a new drug application for a bladder cancer treatment drug filed in defiance of U.S. Food and Drug Administration advice. 

The FDA had warned Spectrum not to file a new drug application for Apaziquone using data from two clinical studies that regulators said didn't provide satisfactory data, the complaint said. But Spectrum in December 2015 submitted an NDA for the drug that included a post-hoc analysis of pooled data from the clinical studies...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!