Opioid Withdrawal

• FDA approval · 2025-10-22
  FDA Approved: LOFEXIDINE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals, Inc.'s original Abbreviated New Drug Application to market a generic lofexidine product.

• FDA approval · 2024-09-05
  FDA Approved: LUCEMYRA — Supplemental Application (USWM, LLC)

  The FDA approved a supplemental NDA for Lucemyra (lofexidine hydrochloride) submitted by US WorldMeds, LLC.

• FDA approval · 2018-05-16
  FDA Approved: LUCEMYRA — Original Application (USWM, LLC)

  FDA approved LUCEMYRA (lofexidine hydrochloride) as an original NDA for reducing opioid withdrawal symptoms during detoxification.

• FDA approval · 2013-01-11
  FDA Approved: DURACLON — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for DURACLON (clonidine hydrochloride) from Mylan Institutional LLC, adding to the existing approved…