Merck & Co. have a new combo cholesterol drug that includes a generic version of Lipitor (Atorvastatin ) with Merck’s cholesterol medicine, Zetia. Lipitor is part of the widely used class of drugs called statins that reduce the amount of cholesterol naturally produced in the liver. Zetia, on the other hand, reduces the amount of cholesterol absorbed from the food the patient eats. Both drugs are used to lower the LDL, also known as bad cholesterol. Approval
This drug could boost Merck’s sagging cholesterol franchise by essentially replacing its existing combo pill, Vytorin, with one likely to be seen as more powerful. U.S. drugs regulators failed to approve it, at least for now, the company said on Monday, March 5. The Food and Drug Administration issued a so-called Complete Response Letter for the pill, asking Merck to submit more data. It was unclear exactly which data would be required; therefore it’s also unclear as to how long the ruling might delay the approval of the drug.
However, last year Lipitor maker Pfizer sued, alleging Merck’s application for the FDA to approve the Zetia-atorvastatin combination infringed on a Pfizer patent covering Atorvastatin. A Merck spokeswoman stated Monday that the lawsuit “has the potential for holding up FDA approval of the Merck product until the first quarter of 2014.”[related_posts limit=”5”]