Akorn gets FDA clearance for generic Lotemax

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Akorn gets FDA clearance for generic Lotemax

By Sandra Levy - 04/23/2019
Akorn, a leading specialty generic pharmaceutical company, has announced that it received the Food and Drug Administration’s blessing for its generic Lotemax (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. I’m also pleased that we are in the final stages of preparing for commercial launch,” said Akron president and CEO Douglas Boothe.

Loteprednol etabonate ophthalmic suspension, 0.5%, a generic of Bausch + Lomb's branded product, had a market value of approximately $89 million for the 12 months ended February 2019, according to IQVIA data.

The product is indicated for the treatment of post-operative 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, including allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis and selected infective conjunctivitis.

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