K-V Bankruptcy May Hurt FDA's Unapproved Drug Initiative

Law360, New York (August 8, 2012, 5:40 PM EDT) -- K-V Pharmaceutical Co. claims a U.S. Food and Drug Administration decision to allow cheap compounded drugs to compete with its newly approved brand-name drug drove it to bankruptcy, a move experts say may undermine a key FDA initiative to get unapproved drugs reviewed and regulated.

In its Chapter 11 bankruptcy filing Saturday, K-V blamed its financial troubles on the FDA for undermining its exclusivity on Makena, a drug meant to prevent preterm births. Makena was approved in February 2011, as part of the FDA's efforts to...
To view the full article, register now.

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.