FDA Issues Fifth "Warning" Letter of 2016 Citing Violative Oxtellar XR KOL Spanish-Language Video | Pharma Industry Regulation | Scoop.it

 To say that it has been an anemic year from OPDP’s enforcement letters is a bit of an understatement. This week the agency issued its fifth of the year and if it does not double that number in the next few weeks, it will be the lowest level of enforcement seen from this office of FDA. The untitled letter cited a video for Oxtellar XR – an extended release tablet indicated for adjunctive therapy of partial seizures in adults and children 6-17 years. The product has some specific risks associated with use in the label, including warnings of anaphylactic reactions among others. The video was cited for a lack of adequate directions for use because of the specific language used in the video that OPDP felt broadened the indication of the compound to include all seizure types and because the presentation did not present risk information in conjunction with the benefits. Of the five letters issued this year, four were Untitled Letters and one was a Warning Letter.