October 11, 2007
More Generic Drugs to be Available

The U.S. Food and Drug Administration (FDA) announced this month that it is stepping up its procedures for reviewing generic drug applications, with the objective of making more generics available to consumers and health care providers. Generic drugs, which can come into the market after patent exclusivity expires on the brand-name drugs they replace, generally cost less, often much less, than the brand names. To receive FDA permission to market a generic drug, manufacturers must demonstrate that the generic has the same dosage form, strength, route of administration, and conditions of use as an approved brand-name product and must also show that the generic delivers the same amount of its active ingredient in the same amount of time as the brand-name counterpart. Noting that there are increasing numbers of applications for generics approval, the FDA said it will hire and train new generic drug reviewers and will develop electronic programs for handling applications. The FDA approved a record 682 generic drug products in fiscal year 2007.