FDA Advisory Committee Recommends Approval Of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 Dec 2008 - 2:00 PDT

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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."

About Bausch & Lomb

Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life for people around the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs approximately 13,000 people worldwide. Its products are available in more than 100 countries. More information is available at http://www.bausch.com.

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