Obsessive-compulsive Disorder

• FDA approval · 2022-09-20
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application from ANI Pharmaceuticals for fluvoxamine maleate, corresponding to a modification/expansion of t…

• CLINICAL_TRIALS trial_result · 2022-09-09
  Clinical Trial Update: Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients [Phase 4]

  A Phase 4 clinical trial evaluating the efficacy of Exposure and Response Prevention (ERP) and SSRIs in Chinese patients with Obsessive-Comp…

• 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…

• CLINICAL_TRIALS trial_result · 2022-04-07
  Clinical Trial Update: Tolcapone in Obsessive Compulsive Disorder [Phase 2, Phase 3]

  Phase 2/Phase 3 clinical trial update for tolcapone in obsessive-compulsive disorder has completed with posted results.

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• 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…

• 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.

• CLINICAL_TRIALS trial_result · 2021-10-08
  Clinical Trial Update: Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

  A completed pediatric registry study evaluating the safety of sertraline for obsessive-compulsive disorder, with results posted in 2021.

• 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: 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: 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.

• FDA label_change · 2021-09-20
  FDA Approved: ZOLOFT — Supplemental Application (ROERIG)

  FDA approved a supplemental application for Zoloft (sertraline hydrochloride) submitted by Roerig to update the product labeling.

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  The FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, LLC., enabling a generic fluoxetine product under …

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fluoxetine from Aurobindo Pharma Limited, granting approval of a generic fluoxetine product.

• FDA label_change · 2021-09-20
  FDA Approved: FLUVOXAMINE MALEATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for fluvoxamine maleate submitted by ANI Pharmaceuticals, resulting in changes to the product la…

• FDA approval · 2021-09-20
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for fluoxetine hydrochloride, enabling marketing of a generic fluoxetine produc…

• CLINICAL_TRIALS trial_result · 2021-09-10
  Clinical Trial Update: Probiotic Treatment in Adult Obsessive-Compulsive Disorder [Phase 4]

  Phase 4 clinical trial on probiotic treatment for obsessive-compulsive disorder has been terminated.

• FDA approval · 2021-09-03
  FDA Approved: PAROXETINE — Original Application (ANI Pharmaceuticals, Inc.)

  ANI Pharmaceuticals received FDA approval for an original ANDA application for paroxetine, a generic antidepressant.

• FDA approval · 2021-09-01
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for fluoxetine hydrochloride from Dr. Reddy's Laboratories Limited (ANDA 078572), updating regulator…

• FDA approval · 2021-08-31
  FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

  FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, confirming the availability of a generic fluoxetine pr…