Alkermes’ Antipsychotic Clears US FDA Panel Amid Calls For Broader Professional Education Plan
Communication and education on samidorphan’s opioid antagonistic effects should focus on health care providers that prescribe opioids as well as psychiatrists that prescribe olanzapine, advisory committee says in endorsing the safety and efficacy of ALKS 3831.
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Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Alkermes’ combo pill of olanzapine and samidorphan gets US FDA approval; company predicts $10m first-year sales as schizophrenia/bipolar patients cycle through treatment options, including generics.
Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.