FDA Approves Generic Ophthalmic Gel for Post-Operative Inflammation and Pain


This approval was granted to generic pharmaceutical company Akorn Operating Company, LLC.


The US Food and Drug Administration (FDA) has approved an Abbreviated New Drug Application (ANDA) submitted by Akorn Operating Company, LLC, for loteprednol etabonate ophthalmic gel, 0.5%, which is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

"We are excited to launch yet another first-to-market generic of a complex ophthalmic,” said Douglas Boothe, President and Chief Executive Officer, Akorn, in a statement. “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%, is also sold under the brand name LOTEMAX GEL, marketed by Bausch + Lomb.

As noted by the IQVIA, United States sales of loteprednol etabonate ophthalmic gel, 0.5% were approximately $35 million for the 12 months ending on December 2020.

A Previous Approval

In 2019, Akorn received FDA clearance to sell loteprednol etabonate ophthalmic suspension, 0.5%, another generic of Bausch + Lomb’s LOTEMAX.

This approval was likewise based off an ANDA submitted by the specialty generic pharmaceutical company.

The product is currently indicated for the treatment of post-operative inflammation following ocular surgery.

Furthermore, it can be used to treat steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe, including allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis and selected infective conjunctivitis.

The product was officially launched on June 28, 2019.

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