Dyloject Approval Status

  • FDA approved: No
  • Brand name: Dyloject
  • Generic name: diclofenac sodium
  • Company: Javelin Pharmaceuticals, Inc.
  • Treatment for: Pain

Dyloject (diclofenac sodium injection) is an IV non-steroidal anti-inflammatory drug (NSAID) in development for the management of acute moderate-to-severe pain in adults.

FDA Approval Status for Dyloject

DateArticle
Feb 17, 2010Javelin Pharmaceuticals' Receives FDA PDUFA Date for Dyloject NDA
Feb  2, 2010FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review
Dec  2, 2009Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)