FDA approves first generic loteprednol eyedrop

Akorn, Inc. announced the approval of their generic steroid eyedrop, loteprednol etabonate ophthalmic suspension 0.5%.

“This is a really exciting approval for Akorn as we believe it is a first generic approval for loteprednol suspension and it highlights our ability to execute on development and manufacturing of complex ophthalmic suspensions,” said Douglas Boothe, Akorn’s president. “I’m also pleased that we are in the final stages of preparing for commercial launch.”

The suspension is intended for postoperative inflammation after ocular surgery and steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Sales of the drug, sold under the brand names Lotemax and Alrex, were approximately $89 million over a 12-month period, according to the press release.

The approval marks the second time this year that the FDA has cleared an ophthalmic formulation of loteprednol. The agency previously green-lighted Bausch + Lomb's new formulation of loteprednol, Lotemax SM 0.38%, in February 2019.