Generic drug approvals in U.S. set record in 2015

A record number of generic drugs—more than 700—were awarded either final or tentative approval in 2015, FDA says in a recent report. An annual report issued by the Office of Generic Drugs shows that 580 generic drugs were cleared for marketing and another 148 were tentatively approved during the year. FDA issues a tentative approval letter to a generic product applicant when the patents on the original brand-name medicine have not yet expired. A product that has tentative approval cannot be sold in the U.S. The report indicates that FDA rejected nearly 1,300 generic drug applications in 2015 and directed the manufacturers to fix problems. The agency, meanwhile, has essentially eliminated a backlog that once included more than 1,100 applications and is able to inform companies within about 40 days whether their application is sufficient for a full FDA review. In addition, the report touts FDA’s science initiatives to help the generics industry develop products that currently exist only in brand-name form. These include drugs that are inhaled or applied topically and are difficult to reproduce.