Akorn announced that it received an abbreviated new drug application (NDA) approval from the FDA for loteprednol etabonate ophthalmic suspension, 0.5%.
Loteprednol etabonate 0.5% is indicated for the treatment of postoperative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
“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,” Douglas Boothe, Akorn’s President and Chief Executive Officer, said in a company news release. “I’m also pleased that we are in the final stages of preparing for commercial launch.”
The branded version of Loteprenol etabonate 0.5% is Bausch + Lomb’s Lotemax, which first received FDA approval in 1998. Earlier this year, Bausch + Lomb received approval for LOTEMAX SM (loteprednol etabonate ophthalmic gel 0.38%), which delivers a submicron particle size for faster drug dissolution in tears than Lotemax Gel.
According to IQVIA, U.S. sales of loteprednol etabonate ophthalmic suspension 0.5% were approximately $89 million for the 12 months ending February 2019.