News
Complete Response letter for NDA for Ketarx (ketamine) for the treatment for levodopa-induced dyskinesia in Parkinson’s disease.- PharmaTher Holdings
The CRL is similar to the review letter FDA provided on possible deficiencies identified by Quality, as announced on February 12, 2024, and no additional deficiencies were mentioned in the CRL. As such, the Company has completed the necessary tests and responses to address the FDA’s comments and will submit them to the FDA for their review and response to a new GDUFA goal date. The Company will provide updates as they occur.
Condition: Parkinsons-LID
Type: drug
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