Amneal Receives FDA Approval for Difluprednate Ophthalmic Emulsion

Amneal Receives FDA Approval for Difluprednate Ophthalmic Emulsion

November 23, 2021

Amneal Pharmaceuticals announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for difluprednate ophthalmic emulsion 0.05%, which is the generic version of Durezol and is used in the treatment of inflammation and pain associated with ocular surgery.

“With the approval of difluprednate, a complex ophthalmic suspension product, we continue to shift our portfolio to increasingly complex and more differentiated product areas. The wheel of innovation constantly turns at Amneal, and we see a long runway for our R&D engine,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

According to IQVIA, yearly sales of Durezol and its generic equivalents in the United States were around $103 million in the 12 months ending September 2021.

As with other ophthalmic corticosteroids, Difluprednate Ophthalmic Emulsion, 0.05% can cause posterior subcapsular cataracts, raise the risk of secondary eye infections, and delay healing due to an increased incidence of bleb development.

Long-term use can cause glaucoma, which causes damage to the optic nerve, as well as impairments in visual acuity and field of vision. Difluprednate should not be used if you have a fungal infection of the ocular structures, a viral infection of the cornea and conjunctiva, or a Mycobacterial infection of the eye.

Reported adverse drug reactions include blepharitis; conjunctival edema; corneal edema; posterior capsule opacification; anterior chamber flare; ciliary and conjunctival hyperemia; anterior chamber cells; and eye pain.

About Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. is a specialty pharmaceutical company with a strong generics business in the United States and a rising branded business. The company’s team is working together to create one of the most dynamic pharmaceutical companies in our fast-paced industry.

The company’s mission is to deliver outcomes that meet important medical needs, make quality medicines more accessible and more affordable, and provide solutions for tomorrow’s health challenges.