Other terms
- Acid Reflux
- Acute Coronary Syndrome (ACS)
- Acute Hepatic Failure
- Acute Myocardial Infarction
- Advanced Lung Squamous Cell Carcinoma (LUSC)
- Adverse event
- Adverse Event Grading
- Age-Related Macular Degeneration (AMD)
- Aging Hands
- Alopecia Areata
- Alzheimer’s Disease
- Angina Pectoris
Abbreviated New Drug Application (ANDA)
What is an Abbreviated New Drug Application (ANDA)? An Abbreviated New Drug Application is used to seek approval from the FDA for manufacturing and marketing a generic drug product. The purpose is to produce an alternative to the brand-name drug that is equally effective for the given indication but is lower in cost.
What is required by the ANDA?
Unlike a new drug application (NDA) used to gain approval for novel drugs, the ANDA does not usually require all the components needed for the NDA, including data from pre-clinical and clinical studies previously used to establish drug safety and efficacy.
ANDA instead requires that the manufacturer can show bioequivalence to the brand drug, with similarity demonstrated in:
- Drug ingredients, including quality and purity
- Intended use
- Pharmacokinetics
- Pharmacodynamics
- Route of administration
- Dosage forms and strength
Source:https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application- anda#:~:text=An%20abbreviated%20new%20drug%20application,brand%2Dname%20d
rug%20it%20references.
