FDA Approved Drugs
Use our drug profile search engine to review information about current FDA approved cancer drugs.
A chemotherapy drug or supportive care agent may be referred to by different names. Typically, when a drug is first approved by the FDA for clinical use, the trade name selected by the manufacturer is used. However, the same agent may also be referred to by its chemical name. Once the original manufacturers patent on the drug has expired, other manufacturers, with FDA approval, are allowed to produce and market the same chemical compound which is typically referred to as a “generic” form of the original. Sometimes these manufacturers will market the generic form under a new trade name to help identify it in the marketplace. Finally, the actual chemical name of the compound is sometimes used by medical professionals rather than the trade name or generic name.
Our drug dictionary is organized by alphabet, including both generic and trade names. Alternately, you may view a list of drugs by “class.”
Following discovery, an experimental drug may take 12-15 years before it is approved for use by the FDA in cancer patients. Promising new agents first undergo pre-clinical testing in animals and are designated by the FDA as an Investigational New Drug (IND) if the pre-clinical data is positive. Research then moves on to human subject clinical testing through Phase I, II and III clinical trials.
Following an average of seven years of clinical trials the manufacturer may submit a New Drug Application (NDA) to the FDA if the data demonstrates that the drug is both safe and effective. Once the NDA receives FDA approval, the FDA will issue official guidelines for administration of the drug.
The manufacturer may then make the new drug available to physicians to prescribe for patients. The manufacturer must continue to submit safety and effectiveness data as mandated by the FDA. The FDA may also require post-marketing Phase IV clinical trials to test further formulations, dosages, durations and drug comparisons as well as long-term toxicity. If a manufacturer chooses to expand the approved indication, it must conduct new Phase II and III clinical trials.