FDA Wants Another "Black Box" Warning For Avandia

Law360, New York (October 24, 2007, 12:00 AM EDT) -- Amid growing concerns over the safety of Avandia, the U.S. Food and Drug Administration is reportedly pushing for the diabetes drug's manufacturer GlaxoSmithKline PLC to add an additional so-called “black box” warning about heart-attack risk to the label.

Officials at the agency are currently in the midst of talks with the pharmaceutical giant over the final form of the new label, which the FDA wants to include the tougher warning, the Wall Street Journal reported Wednesday, citing sources familiar with the matter.

Glaxo already agreed in...
To view the full article, register now.

Law360 UK

UK Financial Services

Read Our Latest UK Legal News & Analysis

Financial Services Law360 UK and Insurance Law360 UK provide breaking news and in-depth analysis on U.K. and European Union regulation, enforcement, legislation, and litigation involving banks, investment firms, insurers, and more.