Akorn granted new drug application for ophthalmic gel 3.5%

Key Points

Lake Forest, IL-Akorn Inc. has announced approval of an FDA new drug application (NDA) for ophthalmic gel 3.5% (Akten), a topical, ocular anesthetic formulation. The gel is the first NDA ocular anesthetic approved by the FDA in 40 years, and it was expected to be commercially available last month, according to a prepared statement issued by Akorn.

The novel, unit dose is a preservative-free lidocaine gel that is intended to be used in any ocular procedure that requires a topical anesthetic agent.

"This is a very important milestone in our company's history, because it represents our first internally developed NDA drug product," said Arthur S. Przybyl, Akorn's president and chief executive officer. "We expect [the ophthalmic gel] to become the standard of care whenever an ocular anesthetic is prescribed. [It] will be manufactured at our Somerset, NJ, facility, and [it] will be marketed directly to hospitals and ophthalmologists, with a targeted detail sales effort by our 65 sales representatives."