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Merck Uses 505(b)(2) for New Combo

On May 3, 2013 FDA approved Merck’s  Liptruzet, which combines the its Zetia (ezetimibe) and atorvastatin – Pfizer’s Lipitor which has gone generic.  According to the Merck press release, Liptruzet was approved “for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.”

Of  course, Merck had already developed a very similar drug with its own statin, simvastatin, in combination with ezetimibe, in the combination drug Vytorin (since done generic). Thus Liptruzet is a means for Merck to extend its franchise a few more years, on the back of Pfizer’s drug.  Readers will note that Pfizer could have used the Merck product to develop the same combination product.

Note: The FDA website states that the approval is a “ New ester, new salt, or other noncovalent derivative” which is incorrect.  Hopefully the FDA will correct this.