Recalls and OTC Disapproval: A Gloomy December for Merck

pills_jpg.jpgThis is definitely not Merck’s month.

On 12 December 2007, Merck announced the voluntary recall of potentially contaminated batches of the influenza vaccines PEDVAXHIB and COMVAX. These vaccines are indicated for infants and young children for protection against the seasonal flu and hepatitis B. The affected batches were distributed in April 2007 [1].

On another front, a US FDA advisory panel voted against Merck’s application for the prescription drug Mevacor 20 mg to be sold over-the-counter. Mevacor (lovastatin) is indicated for the treatment of elevated cholesterol levels. It has been on the market as a prescription drug since 1997. The panel’s recommendation is based on concerns of the use of the drug by misinformed consumers who may not actually benefit from it. The recommendation is not binding and a final decision would be reached in January 2008 [2].

Merck News Item, 12 Dec 2007

Merck News Item, 13 Dec 2007

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December 18, 2007. Regulatory, Vaccines, Drug development. No Comments.

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