Merck: FDA won’t OK combo choles­terol drug

The Washington Times Daily - - Business -

WHITE­HOUSE STA­TION | Fed­eral reg­u­la­tors have de­cided not to ap­prove a new com­bi­na­tion choles­terol drug made by Merck & Co., at least for now.

The drug­maker says the Food and Drug Ad­min­is­tra­tion in­formed the com­pany it will need more data be­fore it can ap­prove the medicine.

The Merck ex­per­i­men­tal drug com­bines the com­pany’s choles­terol drug Ze­tia with a generic ver­sion of ri­val Pfizer Inc.’s Lip­i­tor, which had been the top-sell­ing drug of all time.

Merck says com­pany of­fi­cials will talk with the FDA to de­ter­mine the next steps for try­ing to win ap­proval. Merck says some new data ex­pected later this year may ad­dress the FDA’S con­cerns.

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