Amneal Receives Approval for Difluprednate Ophthalmic Emulsion
- Represents the latest generic ophthalmic product approval for Amneal
BRIDGEWATER, N.J.--(BUSINESSWIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today 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®, U.S. annual sales for Durezol® and its generic equivalents in the 12 months ended September 2021 were approximately $103 million.
Difluprednate Ophthalmic Emulsion, 0.05%, as with other ophthalmic corticosteroids, may result in posterior subcapsular cataract formation; increase the hazard of secondary ocular infections, and delay healing with the increase in the incidence of bleb formation. Glaucoma can also result from prolonged use, with damage to the optic nerve, defects in visual acuity, and fields of vision. Difluprednate use is contraindicated in fungal disease of ocular structures; viral diseases of the cornea and conjunctiva; and 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.
See Package Insert (PI) for full prescribing information including Safety Information: https://www.amneal.com/wp-content/uploads/2021/11/Amneal-Difluprednate-ophthalmic-emulsion-PI-Rev-10-2020-01.pdf
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics business and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty business, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE business, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.
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Senior Director, Investor Relations