Major Depressive Disorder

• FDA approval · 2026-04-22
  FDA Approved: QUETIAPINE FUMARATE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for quetiapine fumarate from Accord Healthcare Inc., updating the product's labeling and/or indicati…

• FDA approval · 2026-04-13
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  FDA approved a supplemental application for SPRAVATO (esketamine hydrochloride) from Janssen Pharmaceuticals Inc.

• FDA approval · 2026-04-09
  FDA Approved: DULOXETINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves a supplemental application for duloxetine hydrochloride as a generic product from Alembic Pharmaceuticals Limited.

• FDA approval · 2026-03-27
  FDA Approved: ESCITALOPRAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic escitalopram product (ANDA 078169).

• FDA approval · 2026-03-26
  FDA Approved: PAROXETINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals Inc.'s supplemental application for paroxetine (generic). This marks approval of a generic paroxeti…

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• FDA approval · 2026-03-13
  FDA Approved: CITALOPRAM — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for a generic citalopram product from Aurobindo Pharma Limited.

• FDA approval · 2026-03-04
  FDA Approved: DESIPRAMINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Desipramine hydrochloride by Amneal Pharmaceuticals NY LLC, authorizing the generic product (AND…

• FDA approval · 2026-02-25
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Apnar Pharma LP)

  FDA approved a supplemental application for bupropion hydrochloride from Apnar Pharma LP, granting approval for the supplemental use of this…

• FDA approval · 2026-02-18
  FDA Approved: ARIPIPRAZOLE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for aripiprazole from Aurobindo Pharma Limited, providing a generic version of the antipsychotic. The approva…

• FDA approval · 2026-02-09
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application from Apotex Corp for trazodone hydrochloride, granting approval of a generic version of the antidepr…

• FDA approval · 2026-02-09
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for trazodone hydrochloride tablets from Apotex Corp, reflecting an additional approval or change to…

• FDA approval · 2026-01-30
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for the olanzapine and fluoxetine combination, expanding/adjusting its labeling under Teva's ove…

• FDA approval · 2026-01-30
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for the olanzapine and fluoxetine combination (olanzapine + fluoxetine) submitted by Par Health USA,…

• FDA approval · 2026-01-30
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride (ANDA201272) from Marlex Pharmaceuticals, Inc., authorizing continued …

• FDA approval · 2026-01-28
  FDA Approved: SERTRALINE HCL — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal's generic sertraline hydrochloride tablet via an original ANDA. This decision enables generic competition for sertraline…

• FDA approval · 2026-01-20
  FDA Approved: SERTRALINE HYDROCHLORIDE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA-approved original application for sertraline hydrochloride generic (Dr. Reddy's Laboratories) for multiple indications.

• FDA approval · 2026-01-20
  FDA Approved: SERTRALINE HCL — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s sertraline hydrochloride generic (SERTRALINE HCL) under ANDA218342, expanding access to the generic formul…

• EMA approval · 2026-01-19
  EMA Authorised: Brintellix (vortioxetine) — H. Lundbeck A/S

  The European Medicines Agency authorised Brintellix (vortioxetine) by H. Lundbeck A/S for major depressive disorder.

• FDA approval · 2026-01-15
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a fluoxetine generic product manufactured by Aurobindo Pharma Limited.

• FDA approval · 2026-01-14
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for a fixed-dose combination of olanzapine and fluoxetine, adding its use for depressive episod…

• FDA approval · 2026-01-13
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for the generic combination of olanzapine and fluoxetine, manufactured by Par Health USA, LLC.

• FDA approval · 2026-01-07
  FDA Approved: PROTRIPTYLINE HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)

  FDA approved the supplemental application for Protriptyline Hydrochloride from Epic Pharma, LLC, authorizing the continued marketing of the …

• FDA approval · 2026-01-07
  FDA Approved: QUETIAPINE — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved Accord Healthcare Inc.'s supplemental application for quetiapine (generic), indicating approval of a modification to an alr…

• FDA approval · 2025-11-20
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for sertraline hydrochloride manufactured by Aurobindo Pharma Limited. This approval covers a generi…

• FDA approval · 2025-11-13
  FDA Approved: RALDESY TM — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for RALDESY TM (trazodone hydrochloride, oral) from Validus Pharmaceuticals LLC.