April 22, 2019
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FDA approves generic loteprednol etabonate from Akorn

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The FDA has approved an abbreviated new drug application for Akorn’s loteprednol etabonate ophthalmic suspension 0.5%, according to a press release.

“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, the company’s president and CEO, said in the release. “I’m also pleased that we are in the final stages of preparing for commercial launch.”

Indicated for the treatment of postoperative inflammation after ocular surgery, as well as for steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment, loteprednol etabonate ophthalmic solution 0.5% sales were approximately $89 million in the 12 months that ended February 2019, the release said.