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Akten Approval History

  • FDA approved: Yes (First approved October 7th, 2008)
  • Brand name: Akten
  • Generic name: lidocaine hydrochloride
  • Dosage form: Ophthalmic Gel
  • Company: Akorn, Inc.
  • Treatment for: Ocular Anesthesia

Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.

Development History and FDA Approval Process for Akten

Oct  8, 2008Approval Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5%
Jun  4, 2008Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5%
Jun 29, 2007Akorn, Inc. Announces the New Drug Application Filing for Akten

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