Merck suspends availability of Trepadtive Merck announced the company is taking steps to suspend the availability of Trepadtive tablets worldwide. Trepadtive is not approved for use in the United States. Merck is taking these steps based on the current understanding of the preliminary data from the HPS2-THRIVE study, and in consultation with regulatory authorities. As previously reported by Merck, HPS2-THRIVE did not achieve its primary endpoint of reduction of major vascular events, and there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received Trepadtive compared to statin therapy. The decision to suspend availability of the medicine is aligned with the recommendation of the European Medicine Agency's Pharmacovigilance Risk Assessment Committee based on the trial's results.
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FDA approves Belsomra sleep drug The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.