LAKE FOREST, Ill., Feb. 11, 2021 /PRNewswire/ — Akorn Operating Company LLC (Akorn), a leading specialty pharmaceutical company, announced that it received approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Loteprednol Etabonate Ophthalmic Gel, 0.5%.
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.
Loteprednol Etabonate Ophthalmic Gel, 0.5% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Akorn develops, manufactures and markets specialty pharmaceuticals, including prescription, consumer health and animal health products. As an industry leader in branded and generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products. Additional information is available on Akorn’s website at www.akorn.com.
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