'As labeled'

Phrase: "As labeled"
From: unnumbered warning letters dated March 10 and March 16, 2010, to Glenmark warning letter and Konec warning letter, respectively

In recent warning letters to Gelnmark and Konec for marketing unapproved and misbranded nitroglycerin tablets, the FDA relies solely on drug listing information.

Drug listing mentions in warning letters are usually accompanied by the manufacturing practice observations of inspectors during a facility visit, explain Kurt Karst and Dara Katcher Levy at Hyman, Phelps & McNamara. "Expect to see more Warning Letters directly from the Office of Compliance based solely on drug listing information," they write, especially given the FDA's Unapproved Drugs Initiative.


'As labeled'