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KETARx FDA Approval History

FDA Approved: Yes (First approved August 7, 2025)
Brand name: KETARx
Generic name: ketamine hydrochloride
Dosage form: Injection
Company: PharmaTher Holdings Ltd.
Treatment for: Pain

KETARx (ketamine hydrochloride) is a general anesthetic for use in surgical pain management.

Development timeline for KETARx

DateArticle
Aug 11, 2025Approval FDA Approves KETARx (ketamine) for Surgical Pain Management
May 16, 2025PharmaTher Announces FDA Extends Review Period for Ketamine
Mar 11, 2025PharmaTher Receives US FDA Approval Goal Date for Ketamine
Feb 12, 2025PharmaTher Provides Update on FDA New Drug Application for Ketamine
May 25, 2021PharmaTher Files for FDA Orphan Drug Designation for Ketamine to Treat Lou Gehrig’s Disease

Further information

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