What application must a manufacturer submit to bring a generic medication to market?

A manufacturer must submit an Abbreviated New Drug Application (ANDA) to bring a generic medication to market. The ANDA is specifically designed for generic drugs and allows manufacturers to demonstrate that their product is bioequivalent to the brand-name counterpart. This means that the generic version must have the same active ingredients, dosage form, strength, route of administration, and conditions of use as the original branded drug.

The ANDA process is streamlined compared to a New Drug Application (NDA), which is required for new medications that have not previously been approved. Because generics rely on the safety and efficacy data from the original brand-name drug, the ANDA does not require the same level of clinical data or extensive trials, thus expediting the approval process for generic medications.

In summary, the requirement to submit an ANDA allows for increased access to affordable medications through the introduction of generic alternatives, following the patent expiration of brand-name drugs.