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Akten Approval History

FDA Approved: Yes (First approved October 7, 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

DateArticle
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

Further information

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