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Akorn Receives 2 Generic Nose Spray Approvals

Shanthi Rexaline

Shares of specialty generic pharma company Akorn, Inc. (NASDAQ: AKRX) are advancing solidly Monday morning thanks to twin announcements announced late last week.

What Happened

Akorn said the FDA greenlighted two of its generic candidates: 1) fluticasone propionate nasal spray USP, 50 mcg per spray and 2) loteprednol etabonate ophthalmic suspension, 0.5 percent.

The fluticasone propionate nasal spray, indicated as a temporary relief for hay fever and other upper respiratory allergies in adult and pediatric patients 4 years and older, is an over-the-counter medication and a generic version of GlaxoSmithKline plc (NYSE: GSK)'s Flonase. The loteprednol suspension is a generic version of Bausch Health Companies Inc (NYSE: BHC) unit Bausch + Lomb's branded drug Lotemax.

It's indicated to treat post-operative inflammation following ocular surgery and steroid responsive inflammatory conditions of the eye.

Why It's Important

Loteprednol etabonate ophthalmic suspension 0.5 percent generated sales of about $89 million in the 12-month period ended February, Akorn said, citing IQVIA.

Akorn said it's in the final stage of the commercial launch of loteprednol suspension.

In pre-market trading Monday, Akorn's stock traded higher by 10.8 percent to $3.07 per share.

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