Merck (MRK), known as MSD outside the United States and Canada, announced that the U.S. FDA has approved BELSOMRA (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep. BELSOMRA is expected to be available in late 2014 or early 2015.
The FDA has recommended BELSOMRA be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled product. Earlier this year, the DEA proposed a Schedule IV drug classification under the Controlled Substances Act. The company noted that the DEA has not yet issued a final decision on the scheduling for BELSOMRA and therefore product cannot become available before that decision.
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