Trial Profile
A Bioequivalence Study of Dexa ODF: Second Bioequivalence Study for the US
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 22 Feb 2023
Price :
$35
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At a glance
- Drugs Dexamethasone (Primary)
- Indications Chemotherapy-induced nausea and vomiting; Croup; Hypersensitivity
- Focus Pharmacokinetics; Registrational
- Sponsors AcuCort
Most Recent Events
- 20 Feb 2023 According to an AcuCort media release, AcuCort has also had the date for the last submission under the Small Business Waiver brought forward. This also extends the time for exemption from the registration fee of USD 1.6 million, approximately SEK 16.7 million. A new Small Business Waiver application deadline has not yet been provided to AcuCort.
- 20 Feb 2023 According to an AcuCort media release, the FDA has announced that the company needs to submit additional information prior to the company's registration application in the United States which also extends the time for the exemption from registration fee that was previously communicated.
- 01 Mar 2022 According to an AcuCort media release, the US FDA granted company waiver request under the small business waiver provision regarding the application fee for the new drug application (NDA) of dexamethasone (ISICORT). The positive decision means that AcuCort will be exempted from paying an application fee of $US1.6 million, provided that the application will be submitted no later than February 2023. The company had filed an application for a fee waiver in 2021.