FDA Committee Votes Against Rejena Application for Dry Eye Treatment

July 13, 2009

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 6-1 against approval for the eye drop Rejena, River Plate’s proposed treatment for dry eye. The FDA panel stated that the company did not adequately demonstrate the safety and effectiveness of its drug.

The FDA will take the panel’s thoughts into consideration when making the final decision on the drug.

In briefing documents released before the meeting, FDA officials had said that they questioned the robustness of one of the company’s studies.  Panelists echoed the FDA’s concerns and had additional questions about a second study the company submitted for consideration.

If approved, the drug will be marketed by Alcon, Inc.

Read the releases here and here.

 

 



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