Gralise Approval History beta

  • FDA approved: Yes (First approved January 28th, 2011)
  • Brand name: Gralise
  • Generic name: gabapentin
  • Previous name: DM-1796
  • Company: Depomed, Inc.
  • Treatment for: Postherpetic Neuralgia

Gralise (gabapentin) is an extended release, tablet formulation of the approved antiepileptic agent gabapentin, indicated for the once-daily treatment of post-herpetic neuralgia (PHN).

FDA Approval History for Gralise

DateArticle
Jan 31, 2011Approval Depomed Announces US Food and Drug Administration Approval of Gralise (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia
Jun  8, 2010Depomed Announces Acceptance of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796
Mar 31, 2010Depomed Announces Submission of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796

See also...

Gralise (gabapentin) Consumer Information

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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