So who’s in the doghouse? Some of the world’s biggest drugmakers, that’s who. The Sandoz company that belongs to Novartis; Ivax, which was recently bought by Teva Pharmaceuticals; and Actavis Totowa, a unit of the Icelandic company that lost to Barr in a hostile takeover bid for Pliva.

All told, eight manufacturers and 12 distributors were sent FDA warning letters for selling drugs containing ergotamine tartrate, which were used to treat vascular headaches, including migraines. Less than 2 percent of marketed drugs are unapproved, but even doctors don’t realize this, says Deborah Autor, the FDA’s compliance director in the drug division.

This isn’t academic. Most of the companies omitted from their product labels critical warnings about the potential for serious, possibly fatal, interactions with other meds. Hopefully, the FDA action will give execs at these companies migraines until they straighten out the problem.

To read more, go here:

FDA press release;
List of all 20 companies with links to the Warning Letters.

[tags]Actavis, FDA, Ivax, Novartis, Sandoz, Teva, Unapproved Drugs[/tags]