New anaesthetic approved
Akten Ophthalmic Gel 3.5%, a topical anaesthetic for the eye, has become the first new ocular anaesthetic to receive FDA approval in 40 years, according to a statement released by Akorn, Inc, the maker of Akten.
Akten Ophthalmic Gel 3.5%, a topical anaesthetic for the eye, has become the first new ocular anaesthetic to receive FDA approval in 40 years, according to a statement released by Akorn, Inc., the maker of Akten.
Akten, a preservative-free lidocaine gel, is suitable for all ocular procedures requiring administration of a topical anaesthetic, either in hospital or in an office. The gel is designed to be stored at room temperature.
The approval follows Akorn's New Drug Application filing in June 2007, which was submitted after the Phase III clinical trial achieved its primary endpoint. Akorn plans to make Akten available before the end of the month.
