ANDA Process Provides Market Pathway for Generics
When a new pharmaceutical is in development and ready for clinical trials, the company that is producing it must file a New Drug Application (NDA). Conversely, when a generic is being produced, an Abbreviated New Drug Application (ANDA) must be filed. Through the ANDA, the manufacturer must demonstrate to the FDA that the new generic drug is equivalent to the name-brand drug in that it:
- Has the same active ingredient as that of the name-brand drug;
- An active ingredient in a medicine is the component that makes it pharmaceutically active — effective against the illness or condition it is treating;
- Generic drug companies must provide scientific evidence that shows that their active ingredient is the same as that of the brand-name medicine they copy, and FDA must review that evidence;
- Is the same strength as the name-brand drug;
- Is the same type of product, such as a tablet or an injectable;
- Has the same route of administration, such as oral or topical;
- Has the same use indications;
- Has acceptable inactive ingredients;
- Some differences, which must be shown to have no effect on how the medicine functions, are allowed between the generic and the brand-name product;
- Generic drug companies must submit evidence that all the ingredients used in their products are acceptable, and FDA must review that evidence;
- Lasts for at least the same amount of time, as most medicines break down, or deteriorate, over time;
- Generic drug companies must do months-long “stability tests” to show that their products last for at least the same amount of time as the brand-name product;
- Is manufactured under the same strict standards as the brand-name medicine;
- It meets the same batch requirements for identity, strength, purity, and quality;
- The manufacturer is capable of making the medicine correctly and consistently;
- Will be shipped and sold in a container that is appropriate;
- Has the same label as the brand-name medicine;
- The drug information label for the generic medicine should be the same as the brand-name label. One exception is if the brand-name drug is approved for more than one use and that use is protected by patents or exclusivities. A generic medicine can omit the protected use from its labeling and only be approved for a use that is not protected by patents or exclusivities, so long as that removal does not take away information needed for safe use. Labels for generic medicines can also contain certain changes when the drug is manufactured by a different company, such as a different lot number or company name;
- Relevant patents or exclusivities are addressed; and,
- As an incentive to develop new medicines, drug companies are awarded patents and exclusivities that may delay FDA approval of applications for generic medicines. FDA must comply with the delays in approval that the patents and exclusivities impose.
Through the ANDA, generic drug manufacturers must also explain how they intend to manufacture the medicine, providing evidence that each step of the manufacturing process will produce the same result each time. FDA scientists review those procedures and FDA inspectors go to the generic drug manufacturer’s facility to verify that the manufacturer is capable of making the medicine consistently and to check that the information the manufacturer has submitted to FDA is accurate.
