Arbor Pharmaceuticals, LLC
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Latest From Arbor Pharmaceuticals, LLC
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.
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
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