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FDA guides on abuse-deterrent opioids; generics direction pending

 
• By Donna Young

The FDA on 1 April unveiled its final guidance advising makers of brand-name opioids about what they need to do to obtain abuse-deterrent language in the labeling of their products.

The FDA on 1 April unveiled its final guidance advising makers of brand-name opioids about what they need to do to obtain abuse-deterrent language in the labeling of their products.

The document, Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling, describes the FDA's expectations about what types of studies...

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More from Neurological

Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 
• By Andrew McConaghie

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Vigil’s Iluzanebart Disappoints In Rare Neurodegenerative Disease

 
• By Jessica Merrill

The Phase II TREM2 agonist is not part of Sanofi’s planned acquisition.

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By Kevin Grogan

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

More from Therapy Areas

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

UCB Follows Fellow European Pharmas With Major US Investment

 
• By Kevin Grogan

The Belgian drugmaker is boosting its biologics capacity over the pond.