Discovery Experimental and Development, Inc.; Deprenyl Gelatin Capsules and Liquid (Deprenyl Citrate); Proposal to Refuse to Approve a New Drug Application; Opportunity for a Hearing

Resumo

The Food and Drug Administration (FDA) proposes to disapprove a new drug application (NDA) for Deprenyl (deprenyl citrate or deprenyl), submitted by Discovery Experimental and Development, Inc., 29949 S.R. 54 West, Wesley Chapel, FL 33543 (Discovery). FDA is also providing Discovery notice of an opportunity for a hearing on the proposal. The grounds for FDA's proposed refusal to approve are numerous. Most importantly, FDA concludes that there is insufficient information to determine whether Discovery's deprenyl citrate is safe for use or will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling. Discovery's deprenyl citrate is intended for the treatment of Alzheimer's disease.