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FDA Doesn’t Like Brochure on OraVerse by Novalar

March 1st, 2010 · 3 Comments

Dentalblogs has covered OraVerse in previous posts. 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.

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 instructed Novalar, maker of OraVerse, to amend the drug brochure. Read the letter here. 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. 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.

The Novalar CEO, Donna Jansen, says that the brochure in question is no longer in use. If you’re concerned that you may still have copies of the brochure in question, visit xconomy to download a PDF.

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