Arbor Pharmaceuticals, LLC
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Latest From Arbor Pharmaceuticals, LLC
Panel on Arbor Pharmaceuticals' reformulated stimulant highlights the risks of trying to craft a new labeling niche without any FDA guidance or endorsement of the idea.
Arbor Pharmaceuticals’ ADHD drug faces a challenging advisory committee after FDA questions whether even an effective abuse-deterrent stimulant formulation could produce a public health benefit. And the agency isn’t convinced that Arbor’s 505(b)(2) application for its immediate release amphetamine formulation has in fact demonstrated it would reduce abuse and misuse.
Keeping Track: Good News For Deciphera, BMS And Clovis; Bad News For bluebird/BMS, Blueprint And Tonix
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Agency denies citizen petition requests for boxed warning on risk of impulse control behaviors and other psychiatric disorders with the class of drugs used to treat Parkinson’s disease and restless legs syndrome, but agrees with one petitioner that some safety-related changes are warranted.
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