FDA Reversal Puts Alkermes Depression Drug Back On Track For January Approval
Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.
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The novel opioid-system antidepressant is being positioned for adjunctive therapy on top of SSRIs, but Alkermes is eyeing other indications, and better ways to stratify and treat depressed patients.
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