Posted by Michael Wonder on 14 Jul 2016
U.S. FDA grants priority review to Janssen’s new drug application for chewable mebendazole tablets intended to treat soil-transmitted helminthiasis
13 July 2016 - Johnson & Johnson shows ongoing commitment to London Declaration on NTDs through advancement of new chewable tablet.
Janssen Pharmaceuticals announced today that the U.S. FDA has granted priority review designation for the new drug application for a 500 mg chewable tablet formulation of mebendazole. If approved, the chewable mebendazole tablet will provide a treatment and prevention alternative for adults and children aged one year or older with soil-transmitted helminthiasis, also known as intestinal worm infestations.
The FDA grants priority review to therapies that, if approved, may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. This designation shortens the review period to six months compared to 10 months for standard review.
