FDA Requests More Info on PharmaTher’s Ketamine Application
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher citing deficiencies in the company’s abbreviated new drug application for racemic ketamine (Ketarx), the company said. “The deficiencies cited in the CRL are classified as minor,” the company said in a statement. …
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher citing deficiencies in the company’s abbreviated new drug application for racemic ketamine (Ketarx), the company said. “The deficiencies cited in the CRL are classified as minor,” the company said in a statement. …
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