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ISTA submits NDA for once-a-day bromfenac
ISTA Pharmaceuticals Inc. has submitted a new drug application (NDA) to the FDA for its once-a-day formulation of bromfenac sodium ophthalmic solution (Xibrom QD).
Irvine, CA-ISTA Pharmaceuticals Inc. has submitted a new drug application (NDA) to the FDA for its once-a-day formulation of bromfenac sodium ophthalmic solution (Xibrom QD). The company is seeking approval for the drug as a treatment for inflammation, pain, and photophobia following cataract surgery.
The 0.09%, twice-daily formulation of bromfenac, a topical non-steroidal anti-inflammatory (NSAID), was approved in 2005 as the first and only FDA-approved twice-daily NSAID for this indication. It was the fastest-growing ophthalmic product in 2007, according to IMS data. The once-daily formulation contains a higher concentration of the drug.
The twice-a-day drug, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for the drug in 2002 and launched the product in the United States in 2005.
First patient dosed at the Tokyo Medical Center by Belite Bio in Phase 2/3 DRAGON II clinical trial
