Generic drugs are copies that one company makes of a brand-name drug that was developed by another company. Generally, generic drugs sell at lower prices, and it is in the public's interest to get generic drugs to the market quickly. But, like any other scientific and regulatory process, approval of a generic drug takes time. It takes FDA time to review the complex information needed to demonstrate that a given generic drug can be substituted for the brand-name drug that it copies, and that time also depends on the complexity of the drug product and the completeness of the application. Here is why:
Prescription drugs have significant, sometimes life-saving, positive effects, but they also may present significant risks. FDA approves a drug only after review of extensive testing showing that a drug will provide the benefits described in its labeling, and that those outweigh its risks.
As a copy of the brand-name drug FDA originally reviewed, a generic drug application submitted to FDA for approval must show that: