Daily Archives: January 24, 2007

Approvable Letter Issued to Wyeth

Following a rash of approvable letters at the end of 2006 for a number of products, Wyeth Pharmaceuticals announced that it has received an FDA approvable letter on January 22 for Pristiq (TM) – desvenlafaxine succinate – a serotonin-norepinephrine reuptake … Continue reading

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Warning Letter Summary for 4th Quarter 2006

A total of seven companies received Warning Letters during the last quarter, meaning that one-third of the year’s letters came in the final three months of the year.  What we saw is a mix of large and small companies, with … Continue reading

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