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Lucemyra Approval History

FDA Approved: Yes (First approved May 16, 2018)
Brand name: Lucemyra
Generic name: lofexidine hydrochloride
Dosage form: Tablets
Company: US WorldMeds
Treatment for: Opiate Withdrawal

Lucemyra (lofexidine hydrochloride) is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal.

Development History and FDA Approval Process for Lucemyra

DateArticle
May 16, 2018Approval FDA Approves Lucemyra (lofexidine hydrochloride) as the First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms
Mar 27, 2018FDA Advisory Committee Votes in Favor of Lucemyra (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms
Nov 21, 2017U.S. FDA Accepts Regulatory Submission and Grants Priority Review for US WorldMeds' Lofexidine
Jun 16, 2008US WorldMeds Completes Phase III Trial of Lofexidine for Treatmentof Opiate Withdrawal Symptoms

Further information

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