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The FDA Sees a Problem with Valeant’s New Glaucoma Eye Drops

Trading At The NYSE As  Valeant Shares Halted Ahead of News AnnouncementTrading At The NYSE As  Valeant Shares Halted Ahead of News Announcement
The Food and Drug Administration raised concerns over the Bausch + Lomb facility in Florida where Valeant's new eye drops are made.Photograph by Michael Nagle – Bloomberg via Getty Images

Valeant Pharmaceuticals (VRX) said on Friday U.S. regulators have raised concerns over a new eye drop manufactured at a Bausch + Lomb facility in Florida.

The U.S. Food and Drug Administration, in a complete response letter (CRL) regarding the eye drop for a type of glaucoma, raised concerns over Current Good Manufacturing Practice at the unit.

The letter did not identify any efficacy or safety issues with the eye drop, a latanoprostene bunod ophthalmic solution.

Valeant said it intends to meet the regulators and resolve these concerns, the company said in a statement.

 

Eye care unit Bausch + Lomb is one of Valeant’s core assets and a frachise to build on, billionaire investor and Valeant board member Bill Ackman said last week.