Animal & Veterinary
Expiration Dates for Programs® Extended
May 28, 1998
FDA has approved two supplemental new animal drug applications (NADAs) for Lufeneron (Program®). On February 7, 1997, FDA approved a supplemental NADA for Program® Suspension which extended the expiration date on the product for one additional year (to 36 months). Also, on September 19, 1997, FDA approved a supplemental new NADA for Program® Tablets which extended the expiration date on that product for one additional year (to 48 months). FDA based these approvals on supporting stability data submitted by the sponsor of the drugs, Novartis Animal Health.
FDA is responsible for approving original, supplemental, and abbreviated new animal drug applications under the Federal Food, Drug, and Cosmetic Act (the Act). The Act requires that new animal drugs be shown to be safe and effective for their intended uses. It also requires that the methods, facilities, and controls used for the manufacturing, processing, and packaging of the drugs be shown to be adequate to preserve their identity, strength, quality, and purity.
The Code of Federal Regulations (Title 21, Part 514.1) specifies the proper form and information required to be submitted by drug sponsors. One of the requirements of these regulations is that drug sponsors submit data from stability studies that substantiate the request for a specific expiration date and provide information on the stability of the drug product.