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.
The Week Ahead In Biotech: Conferences, Clinical Trial Readouts, Earnings And IPOs
Mustang Bio Gallops Higher On Positive Gene Therapy Results For Deadly 'Bubble Boy Disease'
See more from Benzinga
- The Daily Biotech Pulse: Merck's Keytruda Clinches Another FDA Win, KemPharm Close To NDA Filing For ADHD Drug
- The Daily Biotech Pulse: Bristol-Myers Squibb-Celgene Deal Faces Setback, Syneos Hit By SEC Probe, FDA Cheer For T2 Biosystems
- The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials, Earnings, IPOs
© 2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.