FDA's 1991 generic drug approvals
Executive Summary
The Office of Generic Drugs approved a total of 188 generic drugs last year, including 12 approvals for first generic versions of innovator products, FDA reported in a Jan. 15 "Talk Paper." The agency approved 100 more generic drugs in 1991 than it did in 1990. The generics office also cleared 3,593 generic drug supplements, compared to 2,455 supplements okayed in 1990. Approvable or nonapproval actions or withdrawals were initiated on 2,098 ANDAs and 2,726 supplements....