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