Healthy Skepticism Library item: 15067
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
 
Publication type: news
FDA Sends Abbott Letter Regarding Depakote ER/Depakote Continuum Care Pharmacy Formulary Flashcard
Pharma Live 2009 Jan 30
http://pharmalive.com/news/index.cfm?articleID=601420
Full text:
The FDA posted on its web site yesterday a letter sent to
Abbott Laboratories about its review of a Depakote ER/Depakote Continuum Care Pharmacy Formulary Flashcard (744-160303) (Flashcard) for Depakote (divalproex sodium delayed-release) Tablets (Depakote) and Depakote ER (divalproex sodium extended-release) Tablets (Depakote ER). In the letter, the FDA says, “The Flashcard is misleading because it omits risk information for Depakote and Depakote ER, broadens the indication of Depakote ER, omits indication information for Depakote, and omits material information about Depakote ER.”