Akorn Operating's Loteprednol Etabonate Ophthalmic Gel, 0.5% receives US FDA approval
12 February 2021 -

Akorn Operating Company LLC, a speciality pharmaceutical company, has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.5%, it was reported on Thursday.

The product is intended to treat post-operative inflammation and pain following ocular surgery.

Douglas Boothe, Akorn's president and CEO, said, 'We are excited to launch yet another first-to-market generic of a complex ophthalmic. 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, US sales of Loteprednol Etabonate Ophthalmic Gel, 0.5% were approximately USD35m for the twelve months ended December 2020.