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Edluar Approval History

  • FDA approved: Yes (First approved March 13th, 2009)
  • Brand name: Edluar
  • Generic name: zolpidem
  • Dosage form: Sublingual Tablets
  • Previous name: Sublinox
  • Company: Orexo and Meda AB
  • Treatment for: Insomnia

Edluar (formerly Sublinox) is a fast-acting sublingual tablet formulation of the widely used drug zolpidem. Edluar is approved for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Development History and FDA Approval Process for Edluar

Mar 16, 2009Approval Orexo's Edluar (formerly Sublinox) receives FDA approval for the treatment of insomnia
Jul 29, 2008Meda: The FDA has accepted for filing the registration application for Sublinox
May 15, 2008Orexo Has Submitted the Registration Application for Sublinox (OX22) to the FDA

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