FDA's ANDA activity

Executive Summary

Generic Drugs Division ANDA "actions," including approvals, increased from 2,149 in 1984 to 5,379 in 1985 to 7,430 in 1986, according to agency data distributed at a Nov. 3-4 Pharmaceutical Manufacturers Association meeting. Actual ANDA approvals during the same three years increased from 382 to 389 to 616. Original ANDAs filed with FDA jumped from 470 in 1984 (when the post-1962 ANDA/patent extension law was enacted) to 1,069 in 1985 and 1,062 in 1986; 814 of the ANDA filed in 1986 have been for post-1962 products. Post-1962 approvals have been granted to 14 brandname and 41 generic drug manufacturers since the law was passed. Eight of the generic firms received first-ever post-1962 ANDAs.