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Akorn receives FDA approval for loteprednol etabonate ophthalmic suspension, 0.5%

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LAKE FOREST, Ill. –Akorn announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for loteprednol etabonate ophthalmic suspension, 0.5%. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.

Douglas Boothe, Akorn’s president and chief executive officer, stated, “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.”

According to IQVIA, U.S. sales of loteprednol etabonate ophthalmic suspension, 0.5% were approximately $89 million for the twelve months ended February 2019.

Loteprednol etabonate ophthalmic suspension, 0.5% 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 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.


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