Panic Disorder

• FDA approval · 2022-11-21
  FDA Approved: VENLAFAXINE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for venlafaxine submitted by Ascend Laboratories, LLC.

• FDA approval · 2022-11-15
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith's fluoxetine hydrochloride as an original generic application, allowing the generic product to be marketed wit…

• FDA approval · 2022-11-09
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' original application for fluoxetine hydrochloride, a generic version of fluoxetine.

• FDA approval · 2022-08-30
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for sertraline hydrochloride as a generic, confirming approval under the ANDA p…

• FDA label_change · 2022-08-30
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for a sertraline hydrochloride generic from Quallent Pharmaceuticals Health LLC, updating the labeli…

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• FDA approval · 2022-08-30
  FDA Approved: VENLAFAXINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application (ANDA) for venlafaxine from Zydus Lifesciences Limited, enabling generic access to the antidepressant.

• FDA approval · 2022-08-15
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2022-08-09
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Venlafaxine Hydrochloride (extended-release) submitted by Chartwell RX, LLC.

• FDA approval · 2022-06-29
  FDA Approved: VENLAFAXINE — Original Application (Almatica Pharma LLC)

  The FDA approved an Original Application for Venlafaxine from Almatica Pharma LLC. Venlafaxine is indicated for major depressive disorder, g…

• FDA approval · 2022-03-29
  FDA Approved: FLUOXETINE — Original Application (Micro Labs Limited)

  The FDA approved Micro Labs Limited's original application for a generic fluoxetine product.

• FDA approval · 2022-02-25
  FDA Approved: PAROXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for paroxetine hydrochloride from Zydus Lifesciences Limited, applying to the generic product.

• FDA approval · 2022-01-19
  FDA Approved: PAROXETINE — Supplemental Application (NorthStar Rx LLC)

  The FDA granted a supplemental approval for paroxetine hydrochloride (paroxetine) from NorthStar Rx LLC under an ANDA. This approval confirm…

• CLINICAL_TRIALS trial_result · 2022-01-11
  Clinical Trial Update: Treatments for Anxiety: Meditation and Escitalopram [Phase 4]

  Phase 4 trial update examining meditation and escitalopram for anxiety disorders, completed.

• CLINICAL_TRIALS trial_result · 2021-11-18
  Clinical Trial Update: LUCHAR - Latinos Using Counseling for Help With Asthma and Anxiety Reduction [NA]

  Clinical trial LUCHAR studying counseling for asthma and anxiety reduction has completed; results posted in 2021.

• FDA approval · 2021-11-02
  FDA Approved: PAROXETINE — Original Application (Chartwell RX, LLC.)

  FDA approved a generic paroxetine product under an original ANDA submitted by Chartwell RX, LLC.

• FDA approval · 2021-10-04
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Alvogen, Inc.)

  FDA approves the sertraline hydrochloride generic under an Original Application filed by Alvogen, Inc. The approval enables marketing of a g…

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Fluoxetine Hydrochloride from Lannett Company, Inc., a generic fluoxetine product.

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  FDA approved a supplemental application for fluoxetine submitted by Chartwell Governmental & Specialty RX, LLC.

• FDA approval · 2021-09-21
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Venlafaxine (venlafaxine hydrochloride) from BluePoint Laboratories, confirming the approval of …

• FDA approval · 2021-09-21
  FDA Approved: VENLAFAXINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for venlafaxine from Sun Pharmaceutical Industries (ANDA078627).

• FDA approval · 2021-09-21
  FDA Approved: VENLAFAXINE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic Venlafaxine manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceutica…

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for fluoxetine hydrochloride submitted by PAI Holdings, LLC dba PAI Pharma. The approval updates the…

• FDA approval · 2021-09-21
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride from Teva Pharmaceuticals USA, Inc. The approval pertains to changes t…

• FDA approval · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for fluoxetine submitted by Torrent Pharmaceuticals Limited.

• FDA label_change · 2021-09-21
  FDA Approved: FLUOXETINE — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved a supplemental application for fluoxetine by ScieGen Pharmaceuticals to update the labeling for this generic antidepressant.