An abbreviated new drug application (US FDA ANDA) is a written request an organization sends to the U.S. food and drug administration to ensure the manufacture of a generic drug in the United States. The applications are known as abbreviated because they do not need any unique clinical trials and require less information than a New Drug Application.
What are the key characteristics of a US FDA ANDA?
An ANDA has many characteristics which separate it from an NDA.
- ANDA is permission from U.S. Food and Drug Administration which allows an organization to manufacture generic drugs in the United States.
- The ANDA does not require the applicant organization to conduct any unique clinical trials.
- A US FDA ANDA should be bio-equivalent to the brand name drug, and the applicant organization will have to prove that.
- If a drug passes ANDA, it comes in the Orange Booklist as an FDA-approved medication.
An in-depth understanding of Abbreviating New Drug Applications
A company that wants to manufacture and sell a generic drug in the market needs to prove the bio-equivalence to the same extent as a brand-name drug. Bio-equivalency is the measure of the drug’s ability to reach and work at a specific body part. Statistical analysis shows that there is no significant difference between a generic drug and a brand-name drug. New drugs have to go through a strict clinical trial, but US FDA ANDAs do not have to undergo such rigorous tests. Biosimilars are a new drug type in the ANDA exceptions because they have to go through clinical trials. This exception occurs because biosimilars have a difficult time reaching bioequivalence with brand-name drugs.
The ANDA asks the applicant to list the drug’s name, chemical name, dosage, strengths, administration, and usage with details for analysis. Then ANDA addresses whether the drug is treatment is prescription only, for treating a rare disease, or over the counter. The application may also include supplemental data with research on drug chemistry, manufacturing control strategy, and other technical information.
If the US FDA ANDA gets approval, the generic drug will get its listing inside the Orange Book, which lists all FDA drugs which are safe, low-cost alternative, and effective for the most general population. The ANDA contains information about how safe and effective the drug is in comparison with a brand-name equivalent. The FDA will not approve any drugs which it does not find helpful for the generic public.
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