Treatment-resistant Depression

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

  FDA approved Teva's supplemental application for a generic fixed-dose combination of olanzapine and fluoxetine, expanding access to this ant…

• 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 · 2025-10-09
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  The FDA approved a supplemental application for SPRAVATO (esketamine hydrochloride) filed by Janssen Pharmaceuticals Inc.

• FDA approval · 2025-07-31
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  The FDA approved Janssen's supplemental application for SPRAVATO (esketamine hydrochloride), updating its labeling to reflect the approved s…

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• CLINICAL_TRIALS approval · 2025-06-22
  Clinical Trial Update: Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)

  Esketamine nasal spray has been approved for marketing for treatment-resistant depression. This update confirms the regulatory approval stat…

• FDA approval · 2025-05-15
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Spravato (esketamine hydrochloride) submitted by Janssen Pharmaceuticals. The action updates…

• FDA approval · 2025-04-28
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  FDA approves a supplemental application for SPRAVATO (esketamine hydrochloride) submitted by Janssen Pharmaceuticals Inc.

• FDA approval · 2025-03-24
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  FDA approved Janssen's supplemental application for SPRAVATO (esketamine hydrochloride) under NDA 211243, updating the product's indications…

• FDA approval · 2025-01-17
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

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

• FDA approval · 2024-12-31
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  FDA approved Janssen's supplemental application for SPRAVATO (esketamine hydrochloride), finalizing a labeling update under NDA 211243.

• FDA approval · 2023-05-01
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

  FDA announces a supplemental approval for a generic fixed-dose combination of olanzapine and fluoxetine by Par Health USA, LLC under ANDA 07…

• FDA approval · 2022-01-03
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  FDA approves Janssen's supplemental application for SPRAVATO (esketamine) to update its labeling for use in depression.

• FDA approval · 2021-02-26
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine product. The combination is indicated for depressive ep…

• FDA approval · 2020-07-31
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

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

• FDA approval · 2019-06-25
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  FDA approved Janssen's supplemental application for SPRAVATO (esketamine hydrochloride), resulting in labeling changes for the product.

• FDA approval · 2019-05-09
  FDA Approved: SPRAVATO — Supplemental Application (Janssen Pharmaceuticals Inc.)

  The FDA approved a supplemental application for SPRAVATO (esketamine hydrochloride) submitted by Janssen Pharmaceuticals.

• FDA approval · 2019-03-05
  FDA Approved: SPRAVATO — Original Application (Janssen Pharmaceuticals Inc.)

  FDA approved SPRAVATO (esketamine hydrochloride) nasal spray under an original NDA (NDA211243) for treatment-resistant depression in adults.…

• FDA approval · 2012-12-31
  FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for a generic olanzapine and fluoxetine product. This expands access to the olanzapine/fluo…