FDA Rejects Combo Cholesterol Drug by Merck & Co.
Merck & Co.'s new combination cholesterol drug was rejected by federal regulators earlier this week, calling for additional studies on the product.
The Food and Drug Administration rejected the drug, which includes a combination of a generic version of Lipitor and Merck's own cholesterol drug known as Zetia, this past Monday. It remains unclear how long the ruling will last and when the combination drug will finally make it to the market.
The FDA ordered additional inquiries into the drug compound, which is only known for now as MK-0653C. The FDA would like to review further data before giving Merck & Co. the go ahead with the new drug.
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The decision is a setback for the pharmaceutical company, which is fighting to revive its dwindling and fleeting popularity in the cholesterol drug market.
"Merck plans to discuss next steps with the agency in the near future, including new data that are expected to be available late this year, which may address the FDA's comments," Merck & Co. said in a statement.
Although the company has not yet indicated a timeline as to when it plans on releasing the additional information, the studies are expected to be completed within the next few months, according to Matthew Herper of Forbes.
Just last week federal health officials announced a plan to add new warnings to labels on cholesterol fighting drugs that have dangerous side effects including memory loss and elevated blood sugar levels.
Some of the drugs that will receive warnings include medicines such as Pfizer Inc.'s Lipitor, AstraZeneca's Crestor, and Merck & Co. Inc.'s Zocor.
The drugs are considered to significantly reduce the risk of heart attack and heart disease, but the FDA determined that warning labels will enable consumers to take the cholesterol fighting drugs with more "knowledge of their side effects."
