FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop
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The U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee today voted unanimously to recommend approval of Bausch & Lomb’s besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis.
The company has developed this broad-spectrum, anti-infective drop specifically for ophthalmic use.
All new chemical entities such as besifloxacin, a fluoroquinolone, must be reviewed by an FDA advisory committee as part of the approvals review process for new drug applications.
“We are encouraged by this morning’s committee discussion and vote, and look forward to continue working with the FDA to gain final approval,” said Flemming Ornskov, M.D., M.P.H., corporate vice president and global president, Pharmaceuticals, Bausch & Lomb. “Our intent remains to bring this innovative product to market, beginning in the U.S., in 2009.”
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