U.S. FDA delays approval of Glaxo's Requip XL

Related Topics

LONDON | Mon Dec 10, 2007 10:06am EST

LONDON Dec 10 (Reuters) - U.S. regulators have delayed approval of an extended-release version of GlaxoSmithKline Plc's (GSK.L) Requip drug for Parkinson's disease, Europe's biggest drugmaker said on Monday.

Glaxo said it had received a so-called approvable letter for Requip XL, indicating that conditions must be satisfied prior to obtaining final U.S. marketing approval. (Reporting by Ben Hirschler; Editing by Clara Marques)

Related Quotes and News

Company
Price
Related News
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.