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A study of long-acting cosyntropin in patients with adrenocortical insufficiency

Trial Profile

A study of long-acting cosyntropin in patients with adrenocortical insufficiency

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 25 Oct 2019

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At a glance

  • Drugs Tetracosactide (Primary)
  • Indications Adrenal insufficiency
  • Focus Therapeutic Use
  • Sponsors Assertio Therapeutics

Most Recent Events

  • 21 Oct 2019 According to a Assertio Therapeutics media release, its development partner West Therapeutic Development, LLC (West) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for its injectable formulation of long-acting cosyntropin (synthetic adrenocorticotropic hormone, or ACTH). West is seeking approval for use as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency.
  • 26 Feb 2019 New trial record
  • 19 Feb 2019 According to a Assertio Therapeutics media release, the company announced the acceptance for filing from the U.S. Food and Drug Administration (FDA) for its 505(b)(2) New Drug Application for its injectable formulation of long-acting cosyntropin.They plan to launch the drug in the U.S. market by early 2020.The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA's review of long-acting cosyntropin is set for October 19, 2019.

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