Merck (MRK) Sinks On FDA Not Approvable Letter on CORDAPTIVE
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Shares of Merck (NYSE: MRK) are down 7.5% after the company received a Not Approvable action letter from the FDA for the Company's New Drug Application for CORDAPTIVE (MK-0524A) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
CORDAPTIVE is intended to both lower bad cholesterol (LDL) and raise good cholesterol (HDL).
The company said, "We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A."
Merck also reaffirmed the Company's 2008 financial guidance as issued last week and reiterated Merck's confidence in meeting its goal of double-digit annual EPS growth through 2010 excluding certain items.
CORDAPTIVE is intended to both lower bad cholesterol (LDL) and raise good cholesterol (HDL).
The company said, "We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A."
Merck also reaffirmed the Company's 2008 financial guidance as issued last week and reiterated Merck's confidence in meeting its goal of double-digit annual EPS growth through 2010 excluding certain items.
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