Non-24-hour Sleep-wake Disorder

• FDA approval · 2023-01-12
  FDA Approved: TASIMELTEON — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's generic tasimelteon through an original application, enabling a generic version to be marke…

• FDA approval · 2022-12-20
  FDA Approved: TASIMELTEON — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s original ANDA for tasimelteon, establishing a generic version of the sleep-wake disorder medication. Tasimel…

• FDA approval · 2020-12-01
  FDA Approved: HETLIOZ LQ — Original Application (Vanda Pharmaceuticals Inc.)

  FDA approval of Hetlioz LQ (tasimelteon) under the original NDA submitted by Vanda Pharmaceuticals Inc.

• FDA approval · 2014-12-12
  FDA Approved: HETLIOZ — Supplemental Application (Vanda Pharmaceuticals Inc.)

  FDA approved a supplemental application for HETLIOZ (tasimelteon) by Vanda Pharmaceuticals.

• FDA approval · 2014-01-31
  FDA Approved: HETLIOZ — Original Application (Vanda Pharmaceuticals Inc.)

  The FDA granted original approval for Hetlioz (tasimelteon) from Vanda Pharmaceuticals for non-24-hour sleep-wake disorder, a circadian rhyt…

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