Vivitrol's Opioid Abuse Claim Will Likely Need Monitoring and Support Services
• By The Pink Sheet Daily
FDA's Psychopharmacologic Drugs Advisory Committee voted in favor of expanding the indication for Alkermes' alcoholism treatment by lopsided margins, with the caveat that monitoring and support must be provided to patients.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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