FDA rejects Alkermes antidepressant drug ALKS 5461
The company's shares were down more than 4 percent in Monday morning trading after the agency's decision, which itself followed a negative AdCom vote in November.
FDA AdCom smacks down Alkermes antidepressant drug, making approval unlikely
Briefing documents from the Psychopharmacologic Drugs Advisory Committee earlier this week had cast doubt on the chances of a positive vote.
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FDA expert panel throws shade at Alkermes antidepressant drug ahead of AdCom meeting
The Psychopharmacologic Drugs Advisory Committee will meet on Thursday to vote on whether to recommend the FDA approve the drug, ALKS 5461, an opioid for major depressive disorder.