A 505(b)(2) application and an ANDA (Abbreviated New Drug Application) are two different types of applications that pharmaceutical companies submit to the U.S. Food and Drug Administration (FDA) for approval to market a generic drug.
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505(b)(2) Application: A 505(b)(2) application is a type of New Drug Application (NDA) that allows a company to seek FDA approval for a drug that is related to an already approved drug. This application can rely on data from previous studies and does not require the submission of full clinical trial data. The 505(b)(2) pathway is typically used for modifications or improvements to an existing drug, such as a new dosage form or route of administration.
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ANDA (Abbreviated New Drug Application): An ANDA is an application submitted for the approval of a generic version of an already approved drug (known as the reference listed drug or RLD). To obtain approval, the generic drug must demonstrate that it is bioequivalent to the RLD. This means that it must have the same active ingredient, strength, dosage form, and route of administration, and show comparable absorption and distribution in the body.
In summary, a 505(b)(2) application is used for modified or improved versions of already approved drugs, while an ANDA is used for generic versions of already approved drugs.