Huntington Disease

• FDA approval · 2016-02-03
  FDA Approved: TETRABENAZINE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic tetrabenazine under an original ANDA.

• FDA approval · 2015-08-25
  FDA Approved: XENAZINE — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Xenazine (tetrabenazine) from Lundbeck Pharmaceuticals LLC.

• FDA approval · 2015-08-17
  FDA Approved: TETRABENAZINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original application for tetrabenazine (generic), expanding access to a VMAT2 inhibitor for Hunt…

• FDA approval · 2013-08-02
  FDA Approved: XENAZINE — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Xenazine (tetrabenazine) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2012-08-17
  FDA Approved: XENAZINE — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Xenazine (tetrabenazine) by Lundbeck Pharmaceuticals LLC.

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• FDA approval · 2011-07-06
  FDA Approved: XENAZINE — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Xenazine (tetrabenazine) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2011-05-04
  FDA Approved: XENAZINE — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Xenazine (tetrabenazine) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2009-12-09
  FDA Approved: HALOPERIDOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for HALOPERIDOL LACTATE from Hikma Pharmaceuticals USA Inc., authorizing modifications under the AND…

• FDA approval · 2009-12-01
  FDA Approved: XENAZINE — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Xenazine (tetrabenazine) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2009-09-14
  FDA Approved: HALOPERIDOL LACTATE — Original Application (Mylan Institutional LLC)

  FDA approved the original application for HALOPERIDOL LACTATE from Mylan Institutional LLC, authorizing a generic injectable form of haloper…

• FDA approval · 2008-08-15
  FDA Approved: XENAZINE — Original Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved Xenazine (tetrabenazine) under Lundbeck's original NDA.