Drug maker Merck & Co. says that slow going in the testing of Gaboxadol, an experimental insomnia drug it has been touting for more than a year, will delay plans to seek federal approval to sell the medicine. Merck had planned to apply for FDA approval in the first quarter of 2007, but the company now says its filing will be delayed until mid-2007. FDA's review and approval process typically takes nearly a year. Merck blamed the delay on a slow enrollment of patients for human testing.
October 16, 2006 at 12:00 AM
1 minute read
The original version of this story was published on Law.Com
Drug maker Merck & Co. says that slow going in the testing of an experimental insomnia drug it has been touting for more than a year will delay plans to seek federal approval to sell the medicine.
Gaboxadol, which would be the first of a new class of sleeping pills, is being jointly developed by Whitehouse Station-based Merck and H. Lundbeck A/S, a Danish drug company that specializes in medications for psychiatric and neurological disorders.
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