Post-1962 generics
Executive Summary
FDA has approved approximately 150 ANDAs for post-1962 generic drugs out of approximately 1,250 ANDAs (including applications for different dosage forms and strengths) submitted to the agency since the ANDA/patent restoration law became effective, FDA Commissioner Young recently told the House Health & Environment Subcommittee. He said the agency has approved approximately 1,450 generics of pre-1962 drugs.