Petition Asks FDA to Prioritize Generic Trientine ANDAs
In a citizen petition, the Wilson Disease Association asked the FDA to approve two ANDAs from Kadmon Holdings for generic trientine.
The addition of these products to the market could significantly improve the options available to patients with Wilson disease, an inherited condition that causes copper to accumulate in the organs.
There is no compelling reason, according to the petition, why the FDA should not approve generic competitors’ ANDAs as long as they meet accepted quality standards. There are no current unexpired patents or exclusivity for trientine, according to the FDA’s Orange Book.