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Sefelsa Approval Status

FDA Approved: No
Brand name: Sefelsa
Generic name: gabapentin
Dosage form: Extended Release Tablets
Previous Name: Serada
Company: Depomed, Inc.
Treatment for: Postmenopausal Symptoms

Sefelsa (gabapentin) is an investigational extended-release formulation of gabapentin in development for the treatment of menopausal hot flashes.

Development Status and FDA Approval Process for Sefelsa

DateArticle
Jun  3, 2013FDA Issues Complete Response Letter on Sefelsa New Drug Application
Mar  4, 2013Depomed Provides Update on Sefelsa FDA Advisory Committee
Oct 15, 2012Depomed Announces Serada NDA Acceptance and FDA Advisory Committee Meeting
Aug 17, 2012Depomed Announces Submission Of Serada NDA
Apr 18, 2012Depomed Announces Intent to File NDA for Serada for Treatment of Menopausal Hot Flashes

Further information

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