Obstructive Sleep Apnea

• EMA approval · 2026-08-06
  EMA Authorised: Ozawade (pitolisant) — Bioprojet Pharma

  Ozawade (pitolisant) by Bioprojet Pharma has been authorised by EMA for obstructive sleep apnea indications.

• EMA approval · 2025-11-18
  EMA Authorised: Ozawade (pitolisant) — Bioprojet Pharma

  EMA authorised Ozawade (pitolisant) by Bioprojet Pharma. It is indicated for obstructive sleep apnea.

• EMA approval · 2025-09-05
  EMA Authorised: Sunosi (solriamfetol hydrochloride) — Atnahs Pharma Netherlands B.V.

  Sunosi (solriamfetol hydrochloride) has been authorised in the European Union for the treatment of narcolepsy and obstructive sleep apnea; d…

• FDA approval · 2023-06-28
  FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)

  The FDA approved a supplemental application for Sunosi (solriamfetol) from Axsome Therapeutics, Inc., pertaining to updates to the drug's la…

• FDA approval · 2021-10-20
  FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)

  The FDA approval record concerns a supplemental application for Sunosi (solriamfetol) from Axsome Therapeutics, with the submission status s…

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• FDA approval · 2021-05-11
  FDA Approved: MODAFINIL — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application from Apotex Corp. for Modafinil, authorizing a generic version of the wakefulness-promoting drug…

• FDA approval · 2021-01-28
  FDA Approved: MODAFINIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for modafinil submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

• FDA approval · 2020-12-18
  FDA Approved: MODAFINIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for modafinil from Rising Pharma Holdings, Inc., resulting in a labeling change for the product.

• FDA approval · 2019-12-13
  FDA Approved: ARMODAFINIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for ARMODAFINIL submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2019-10-07
  FDA Approved: SUNOSI — Supplemental Application (Axsome Therapeutics, Inc.)

  FDA approved a supplemental application for Sunosi (solriamfetol) from Axsome Therapeutics, Inc.

• FDA approval · 2019-03-20
  FDA Approved: SUNOSI — Original Application (Axsome Therapeutics, Inc.)

  Sunosi (solriamfetol) received FDA approval via an Original Application for the treatment of excessive daytime sleepiness in adults with nar…

• FDA approval · 2015-04-16
  FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)

  The FDA approved a supplemental application for NUVIGIL (armodafinil) filed by Cephalon, LLC.

• FDA approval · 2015-01-15
  FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)

  The FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc., resulting in updated regulatory labeling for the prod…

• FDA approval · 2012-09-27
  FDA Approved: MODAFINIL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic form of modafinil from Rising Pharma Holdings, Inc.

• FDA approval · 2012-09-26
  FDA Approved: MODAFINIL — Original Application (Bionpharma Inc.)

  FDA approved Bionpharma's original application for a generic Modafinil product, authorizing marketing in the United States for the treatment…

• FDA approval · 2009-03-26
  FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)

  FDA approved a supplemental application for NUVIGIL (armodafinil) submitted by Cephalon, LLC. This approval covers changes to the product la…

• FDA approval · 2007-08-17
  FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)

  FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc. to update the product's labeling under the supplemental fi…

• FDA approval · 2006-08-07
  FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)

  FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc., resulting in an approved change to its labeling.