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Gralise Approval History

FDA Approved: Yes (First approved January 28, 2011)
Brand name: Gralise
Generic name: gabapentin
Dosage form: Extended Release Tablets
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).

Development History and FDA Approval Process 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

Further information

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