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PharmaTher Assigned GDUFA Date For Ketamine Application in U.S.
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PharmaTher Assigned GDUFA Date For Ketamine Application in U.S.
Sep 6, 2024 12:14 PM

08:51 AM EDT, 09/04/2024 (MT Newswires) -- PharmaTher Holdings ( PHRRF ) , a specialty pharmaceutical company that jumped near 20% yesterday, said Wednesday the U.S. Food and Drug Administration has assigned a Generic Drug User Fee Amendments of 2022 (GDUFA) goal date of October 29, 2024 for the company's New Drug Application for ketamine.

Ketamine, used for anesthesia and pain relief, has been on the FDA drug shortage list since February 2018.

After ketamin launches in the U.S., PharmaTher ( PHRRF ) will pursue international approvals to support global demand for ketamine as well as its commercial development strategy to treat Parkinson's Disease. PharmaTher ( PHRRF ) will also pursue novel uses and delivery methods of ketamine for mental health, pain, neurological and medical countermeasures indications.

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