Definition of New Drug Application

What is a New Drug Application?

Since 1938, every new drug that is ultimately marketed and sold in the US has had to file a New Drug Application (NDA), and this is the means by which a drug's sponsor asks that the Food and Drug Administration grant its approval.

The NDA must provide enough information to allow reviewers to reach the following conclusions:

Whether the drug has proven to be safe and effective in its intended use.
Whether benefits achieved outweigh the risks.
Whether the drug's proposed labeling or package insert is appropriate, and what type of information it should contain.
Whether the quality, strength and purity of the drug can be maintained in the manufacturing process.

Required documentation must include the complete history of the drug, from the results of animal and human testing, to what ingredients the drug contains and how it is manufactured, processed and packaged.

The chemotherapy drug, Alimta (pemetrexed), the first drug approved for malignant pleural mesothelioma, was submitted by its manufacturer, Eli Lilly & Co., under NDA #021462, and was approved on February 4, 2004.

The FDA process for new drugs.

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