Novalar is the company that markets Oraverse, an injectable drug that helps the body remove local anesthetic more quickly thus allowing a patient to become "unfrozen" faster. It seems that on February 26th, the company received a letter from the FDA stating "The brochure omits and minimizes the risks of the drug while overstating its benefits".
Friday, March 5, 2010
In part, the letter states: "The patient brochure is misleading because it suggests that OraVerse is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience. Specifically, the patient brochure contains the claim, “And now the safety and effectiveness of OraVerse have been successfully demonstrated through clinical trials involving pediatric, adolescent and adult patients ages 4 through 92.” This claim misleadingly suggests that OraVerse is approved for all patients ages 4 through 92, when this is not the case. FDA is not aware of substantial evidence to support efficacy claims in patients under the age of 6 years old. According to the Indications and Usage section of the PI, OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs). Furthermore, the Pediatric Use section of the PI states, “The safety, but not the efficacy, of OraVerse has been evaluated in pediatric patients under the age of 6 years old” (emphasis added)."
For the full FDA letter, click here.
Posted by John Flucke at 6:00 AM