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    FDA raises concerns over Valeant's eye drop

    Written by savita thakur thakur Published On 2016-07-24T15:43:16+05:30  |  Updated On 24 July 2016 3:43 PM IST
    FDA raises concerns over Valeants 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.

    Bausch & LombBill Ackmancomplete response letterCRLcurrent good manufacturing practiceeye dropglaucomaUS Food & Drug AdministrationUSFDAValeant
    Source : Reuters

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    savita thakur thakur
    savita thakur thakur
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