Tuesday, October 4, 2022


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Loteprednol Etabonate Ophthalmic Gel, 0.5% Receives FDA Approval

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February 11, 2021

Akorn Operating Company a leading specialty pharmaceutical company. They have received the approval of its Abbreviated New Drug Application from the U.S. Food and Drug Administration.

Douglas Boothe, Akorn’s President and Chief Executive Officer, stated, “We are excited to launch yet another first-to-market generic of a complex ophthalmic. This approval comes in just over 12 months from submission to the FDA and is the result of strong collaboration among Akorn’s research and development, operations, quality, and regulatory teams.”

According to IQVIA, U.S. sales of Loteprednol Etabonate Ophthalmic Gel, 0.5% were approximately $35 million for the twelve months ended December 2020.

The company notes, Loteprednol Etabonate Ophthalmic Gel, 0.5% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

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