Panic Disorder

• FDA approval · 2012-07-31
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited, authorizing its marketing as a gen…

• FDA label_change · 2012-07-19
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam to update the labeling of Teva's clonazepam product.

• FDA label_change · 2012-07-19
  FDA Approved: CLONAZEPAM — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for Accord Healthcare's clonazepam (generic clonazepam), resulting in updated labeling for the p…

• FDA approval · 2012-06-26
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical’s supplemental application for venlafaxine hydrochloride, a generic product. The approval relates to the sta…

• FDA approval · 2012-05-03
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Effexor XR (venlafaxine hydrochloride) by Viatris Specialty LLC.

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• FDA approval · 2012-05-02
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Vertical Pharmaceuticals, LLC)

  The FDA approved a supplemental application for venlafaxine hydrochloride (Vertical Pharmaceuticals, LLC) to update the product labeling und…

• FDA approval · 2012-04-19
  FDA Approved: FLUOXETINE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Time Cap Laboratories, Inc., updating the regulatory status of thi…

• FDA approval · 2012-04-10
  FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for paroxetine hydrochloride submitted by Apotex Corp.

• FDA approval · 2012-02-28
  FDA Approved: FLUOXETINE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approves a supplemental application for a generic fluoxetine hydrochloride product from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2012-02-28
  FDA Approved: FLUOXETINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves the supplemental application for fluoxetine from Alembic Pharmaceuticals Limited, enabling the generic fluoxetine product to be…

• CLINICAL_TRIALS research · 2011-12-29
  Clinical Trial Update: Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders

  A clinical trial update evaluating generalization paradigm patterns across multiple psychiatric disorders, including major depressive disord…

• FDA approval · 2011-12-27
  FDA Approved: PAROXETINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application from Mylan Pharmaceuticals for paroxetine hydrochloride hemihydrate, authorizing a generic version o…

• FDA approval · 2011-12-15
  FDA Approved: PAROXETINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp. to manufacture and market paroxetine hydrochloride as a generic antidepressant.

• CLINICAL_TRIALS trial_result · 2011-12-13
  Clinical Trial Update: Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks [Phase 3]

  Phase 3 clinical trial update on using levetiracetam to treat panic disorder and lactate-induced panic attacks.

• FDA approval · 2011-12-08
  FDA Approved: ALPRAZOLAM — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for alprazolam submitted by Actavis Pharma, Inc., resulting in changes to the product labeling.

• CLINICAL_TRIALS trial_result · 2011-12-02
  Clinical Trial Update: Breathing Regulation Training for Individuals With Panic Disorder [NA]

  Stanford University conducted a completed clinical trial evaluating breathing regulation training for individuals with panic disorder. The s…

• FDA approval · 2011-11-22
  FDA Approved: FLUOXETINE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for fluoxetine hydrochloride from Time Cap Laboratories, Inc., enabling the generic product Fluoxeti…

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

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

• FDA approval · 2011-09-15
  FDA Approved: CLONAZEPAM — Supplemental Application (Solco Healthcare LLC)

  FDA approved Solco Healthcare LLC's supplemental application for clonazepam under an approved ANDA.

• 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 label_change · 2011-08-22
  FDA Approved: ALPRAZOLAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for alprazolam submitted by Aurobindo Pharma Limited.

• FDA approval · 2011-08-19
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for SERTRALINE HYDROCHLORIDE (Mylan Pharmaceuticals Inc.), indicating regulatory action on this gene…

• 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.