If you’re concerned that you may still have copies of the brochure in question, visit xconomy to download a PDF.Dentalblogs has covered OraVerse in previous posts. Read the letter here. In addition, the brochure states that OraVerse can be administered to children as young as four years old, while it is actually cleared for children six and older. On February 26th, xconomy San Diego published an article that tells us the FDA is not pleased with a marketing brochure published by Novalar. The FDA claims that the brochure minimizes and omits risks and overstates benefits of OraVerse. The FDA claims that the brochure minimizes and omits risks and overstates benefits of OraVerse. Issues such as pain at the injection site, headache, and pain following a dental procedure are not mentioned in the brochure. The Novalar CEO, Donna Jansen, says that the brochure in question is no longer in use. In addition, the brochure states that OraVerse can be administered to children as young as four years old, while it is actually cleared for children six and older. On February 26th, xconomy San Diego published an article that tells us the FDA is not pleased with a marketing brochure published by Novalar. If you’re concerned that you may still have copies of the brochure in question, visit xconomy to download a PDF. The Novalar CEO, Donna Jansen, says that the brochure in question is no longer in use. Published by 

Original source : http://www.dentalblogs.com/archives/administrator/… The drug is intended to reverse the effects of local anesthesia quickly so that patients promptly regain feeling in areas made numb during dental procedures. The FDA instructed Novalar, maker of OraVerse, to amend the drug brochure. The FDA instructed Novalar, maker of OraVerse, to amend the drug brochure. Issues such as pain at the injection site, headache, and pain following a dental procedure are not mentioned in the brochure. The drug is intended to reverse the effects of local anesthesia quickly so that patients promptly regain feeling in areas made numb during dental procedures. Read the letter here. FDA Doesn’t Like Brochure on OraVerse by Novalar
March 1st, 2010 · 3 Comments

Dentalblogs has covered OraVerse in previous posts.

Originally posted 2010-03-19 14:42:35. Republished by Blog Post Promoter