PharmaTher’s Ketamine Formulation Receives CRL From FDA

The FDA Demanded Minor Clarifications From The Canadian Firm

 
• By Adam Zamecnik

After sharing multiple updates to the regulatory status of its ketamine formulation, PharmaTher received a complete response letter from the FDA, which required minor information and clarifications from the company.

(Shutterstock)

PharmaTher has received a complete response letter from the US Food and Drug Administration in response to its abbreviated new drug application for a ketamine formulation, on the grounds of minor deficiencies.

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