Is GonaCon currently available to Federal, State, and local wildlife management agencies?
A. No fertility control agent has been approved by the Food and Drug Administration (FDA) for noninvestigational use on wildlife populations in the United States. Several materials, however, including GonaCon, have been classified as investigational drugs that may be used in rigidly controlled research studies. The GonaCon studies underway in Maryland, New Jersey, and Pennsylvania are being conducted as pivotal studies that are required as part of FDA’s approval process for a new animal drug. The approval process for GonaCon vaccine began in 1997, when FDA established an investigational new animal drug exemption for the GnRH vaccine. All research studies of GnRH vaccine have been conducted under this exemption. NWRC is working with FDA to obtain new animal drug approval for GonaCon with the hopes of then partnering with a private company to take the vaccine to market.
