FDA raises concerns over Valeant's eye drop
Valeant Pharmaceuticals International (VRX.TO) (VRX.N) said 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 franchise to build on, billionaire investor and Valeant board member Bill Ackman said last week.