Akorn obtains FDA green light for loteprednol etabonate ophthalmic gel

Patients having ocular surgery will soon have a new generic medication for post-operative inflammation and pain following their surgery.

The Food and Drug Administration has cleared Akorn’s loteprednol etabonate ophthalmic gel, 0.5%.

"We are excited to launch yet another first-to-market generic of a complex ophthalmic," said Douglas Boothe, Akorn's president and CEO. "This approval comes in just over 12 months from submission to the FDA and is the result of strong collaboration among Akorn's research and development, operations, quality, and regulatory teams."

Loteprednol etabonate ophthalmic gel, 0.5% had a market value of approximately $35 million for the 12 months ended December 2020, according to IQVIA.