What is the difference between authorized generics and ANDA generics?
An Authorized Generic is the innovator’s prescription drug, approved under a New Drug Application (NDA) by the FDA, marketed and distributed by an authorized generic distributor like Patriot with a generic product label. ANDA generics are produced and marketed under an Abbreviated New Drug Application, which relies on the innovator’s safety and efficacy data in the NDA to obtain aproval to market a generic version of the innovator product.
