FDA rejects Merck's insomnia drug
(Reuters) - Merck & Co Inc said the U.S. Food and Drug Administration rejected the company's experimental insomnia drug, citing safety issues.
In a complete response letter to the company, the FDA said the safety data of the drug do not support approval, and advised that lower doses of the medicine should be made available before an approval.
The efficacy of the drug, suvorexant, was established at doses of 10 mg to 40 mg in adults, the FDA said, adding that 10 mg should be the starting dose for most patients.
(Reporting by Esha Dey in Bangalore)
- White House reverses, says Obama met uncle and lived with him during law school
- South Africa mourns Mandela, will bury him on December 15 |
- Flights delayed as air pollution hits record in Shanghai
- RPT-UPDATE 1-Ford leans on global Mustang to burnish overseas image
- Struggling Sears to spin off Lands' End clothing label
Revered by millions as a beacon of hope against oppression and as an archetype of reconciliation, Nelson Mandela leaves behind a grieving nation. Video