The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) today responded to a petition and decided that the original formulation of Opana ER (oxymorphone hydrochloride) Extended-Release Tablets was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed.
The petition was submitted by Endo Pharmaceuticals Inc., the sponsor of original Opana ER and a reformulated version, also called Opana ER, which was designed with the goal of being more difficult to abuse and misuse. After an extensive, science-based review, FDA concluded based on the available data and information that the original formulation of Opana ER was not withdrawn from the market for reasons of safety or effectiveness. As a result, FDA has denied the manufacturer’s petition.
For more information please visit: Opana ER
.png)
No hay comentarios:
Publicar un comentario