Akorn Receives FDA Approval for Loteprednol Etabonate Ophthalmic Gel, 0.5%

Akorn announced that it received approval of its abbreviated new drug application (ANDA) from the FDA for loteprednol etabonate ophthalmic gel, 0.5%, which is indicated for the treatment of postoperative inflammation and pain following ocular surgery.

“We are excited to launch yet another first-to-market generic of a complex ophthalmic,” Douglas Boothe, Akorn’s President and Chief Executive Officer, said in a company news release. “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.”

According to IQVIA, U.S. sales of loteprednol etabonate ophthalmic gel, 0.5% were approximately $35 million for the 12 months ended December 2020.