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PharmaTher Assigned FDA Approval Goal Date for its New Drug Application for Ketamine
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PharmaTher Assigned FDA Approval Goal Date for its New Drug Application for Ketamine
May 10, 2024 6:17 AM

08:55 AM EDT, 05/10/2024 (MT Newswires) -- PharmaTher Holdings ( PHRRF ) , a specialty pharmaceutical company, on Friday said it has received from the U.S. Food and Drug Administration an amendment acknowledgment letter for its priority original abbreviated new drug application for Ketamine.

The FDA has also assigned a generic drug user fee amendments of 2022 goal date of October 29. The regulator had previously identified possible quality deficiencies that PharmaTher ( PHRRF ) addressed by completing the necessary tests and responses to address the FDA's comments.

Ketamine has been on the FDA's drug shortage list since February 2018.

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