Amneal Launches Generic Version of FML Ophthalmic Suspension

The Company received 180-day competitive generic therapy exclusivity from the FDA.

The first generic version of FML suspension (fluorometholone ophthalmic suspension) has been made available by Amneal Pharmaceuticals.

Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. The treatment is administered as 1 drop into the conjunctival sac 2 to 4 times daily. During the first 24 to 48 hours, the dosing frequency may be increased to 1 application every 4 hours. 

Patients should be reevaluated if signs/symptoms fail to improve after 2 days. Intraocular pressure should be monitored if the product is used for 10 days or longer.

Amneal’s Fluorometholone Ophthalmic Suspension 0.1% is supplied as a sterile, white to off-white homogenous suspension in 10mL bottles containing 5mL of product and in 15mL bottles containing 10mL of product.

References:

  1. Amneal launches complex generic fluorometholone ophthalmic suspension. News release. Amneal Pharmaceuticals. January 10, 2024. https://www.businesswire.com/news/home/20240110374733/en/Amneal-Launches-Complex-Generic-Fluorometholone-Ophthalmic-Suspension.
  2. Fluorometholone Ophthalmic Suspension USP, 0.1%. Package insert. Amneal Pharmaceuticals; 2024. http://documents.amneal.com/pi/FluorometholoneOphth-PI.pdf.