Generalized Anxiety Disorder

• FDA approval · 2011-11-22
  FDA Approved: ALPRAZOLAM EXTENDED RELEASE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Alprazolam Extended Release, authorizing an extended-release formulation of alprazolam by Actavi…

• FDA approval · 2011-10-18
  FDA Approved: BUSPIRONE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for buspirone hydrochloride from Mylan Pharmaceuticals Inc. The approval reflects a supplemental…

• FDA approval · 2011-09-27
  FDA Approved: ALPRAZOLAM — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for alprazolam (generic) under Par Health USA, LLC.

• FDA approval · 2011-08-26
  FDA Approved: BUSPIRONE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for buspirone hydrochloride from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2011-08-26
  FDA Approved: BUSPIRONE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for buspirone hydrochloride from Mylan Pharmaceuticals Inc., allowing a generic version of the anxie…

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• FDA approval · 2011-08-23
  FDA Approved: XANAX XR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for XANAX XR (alprazolam) filed by Viatris Specialty LLC.

• FDA approval · 2011-08-23
  FDA Approved: ALPRAZOLAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for alprazolam from Mylan Pharmaceuticals Inc., affecting the generic product's labeling.

• FDA approval · 2011-07-27
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) from Zydus Lifesciences Limited under an ANDA.

• FDA approval · 2011-06-20
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) submitted by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2011-06-07
  FDA Approved: ALPRAZOLAM — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic alprazolam product from Aurobindo Pharma Limited under an Original Application (ANDA).

• FDA approval · 2011-06-01
  FDA Approved: ALPRAZOLAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Alprazolam from Mylan Pharmaceuticals, authorizing a generic alprazolam product. The approva…

• FDA approval · 2011-05-12
  FDA Approved: LEXAPRO — Supplemental Application (Allergan, Inc.)

  FDA has approved a supplemental application for Lexapro (escitalopram) submitted by Allergan, Inc.

• FDA approval · 2011-05-06
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved the original ANDA for Venlafaxine hydrochloride by Dr. Reddy's Laboratories Inc, enabling a generic version of this antidepress…

• FDA approval · 2011-04-14
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for venlafaxine hydrochloride from Zydus Pharmaceuticals USA Inc., authorizing a generic version of the antid…

• FDA approval · 2011-04-14
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for venlafaxine hydrochloride, a generic antidepressant.

• FDA approval · 2011-04-12
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) submitted by Eli Lilly and Company.

• FDA approval · 2011-03-04
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited.

• FDA approval · 2011-01-30
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Paroxetine hydrochloride by Zydus Lifesciences Limited, indicating an update to the labeling or …

• FDA approval · 2010-12-21
  FDA Approved: BUSPIRONE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for buspirone hydrochloride filed by Aurobindo Pharma Limited.

• FDA approval · 2010-12-14
  FDA Approved: VENLAFAXINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic venlafaxine via an Original Application (ANDA). It is indicated for major depressive disorder,…

• FDA approval · 2010-12-10
  FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for paroxetine hydrochloride (paroxetine) submitted by NorthStar Rx LLC. This action represents an a…

• FDA approval · 2010-10-15
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride (generic) from Zydus Lifesciences Limited, authorizing a generic paroxe…

• FDA approval · 2010-08-18
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic venlafaxine hydrochloride under an Original Application. It is indicated for major depre…

• FDA approval · 2010-08-04
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Venlafaxine hydrochloride by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2010-06-28
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's venlafaxine hydrochloride as an Original Application generic (ANDA). The approval enables a generic version of venlafaxi…