Which of the following statements is true regarding ANDA?

The correct answer pertains to the Abbreviated New Drug Application (ANDA) and its specific focus on generic drugs. The ANDA process is designed to ensure that a new generic medication is comparable to an already approved brand name drug in dosage form, strength, route of administration, and indications for use. The FDA evaluates these applications to confirm that the generic product meets the necessary criteria for equivalency, including bioavailability and chemistry.

This means that the ANDA does not concern itself with new chemical entities, which are instead reviewed through the New Drug Application (NDA) process. It also does not limit itself to over-the-counter (OTC) drugs; rather, it can apply to both prescription and OTC generics. Furthermore, one of the significant aspects of ANDA is that it does not require extensive safety studies, as the safety and efficacy of the reference brand drug have already been established. Instead, the focus is primarily on demonstrating that the generic product is bioequivalent to the branded counterpart.