US DEA de-schedules AstraZeneca’s Movantik
The USA’s Drug Enforcement Administration (DEA) has de-scheduled UK pharma major AstraZeneca’s (LSE: AZN) Movantik (naloxegol) as a controlled substance.
Following this ruling, AstraZeneca submitted a request to the Food and Drug Administration for an immediate update to the Movantik label to remove the controlled substance designation.
This step was necessary after the drug was approved by the FDA last year (The Pharma Letter September 17, 2014), as a controlled substance due to its structural relatedness to noroxymorphone. However, during the review of the New Drug Application, the FDA evaluated the abuse potential of Movantik and the approved labelling confirms that the drug has no risk of abuse or dependency.
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