New Drug Application (NDA) and Abbreviated New Drug Application (ANDA)

New Drug Application I New Drug Application Process I Abbreviated New Drug Application I NDA I ANDA

New Drug Application (NDA)

The New Drug Application (NDA) is the one of the types of drug application through which drug product applicants gets approval from FDA for a new pharmaceutical product for sale and marketing in the U.S. The data generated and gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become component of the NDA. 

The goals of the New Drug Application are to supply adequate information to permit FDA reviewer to reach the following key decisions whether the:

• drug is safe and effective in its proposed use
• drug's proposed prescribing information (package insert) is appropriate 
• methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate 

New Drug Application Classification

1.       New Molecular Entity

2.       New Salt of Previously Approved Drug

3.       New Formulation of Previously Approved Drug

4.       New Combination of Two or More Drugs

5.       Already Marketed Drug Product

6.       New Indication for Already Marketed Drug Product

Drug Approval Package Parts

At FDA different teams are responsible for review following parts of NDA:

·         Printed Labeling

·         Medical Review(s)

·         Chemistry Review(s)

·         Pharmacology Review(s)

·         Statistical Review(s)  

·         Clinical Pharmacology Biopharmaceutics Review(s) 

New Drug Application Approval Process

For guidelines to the processing, content, evaluation and approval of applications, please visit the FDA's New Drug Application (NDA) page.

NDA Forms and Electronic Submissions

·         Form FDA-356h.   Application to Market a New Drug, or Biologic for human use

·         Form FDA-356h instructions

·         Form FDA-3397.   User Fee Cover Sheet

·         Form FDA-3331.  New Drug Application Field Report

·         Guidance Documents for Electronic Submissions 

Abbreviated New Drug Application (ANDA) 

Generic drug applications are also called "abbreviated new drug applications" (ANDA). ANDA are generally does not require to include animal (preclinical) studies and human (clinical) studies to establish safety and effectiveness of medicinal products. Generic drug product applicants must demonstrate scientifically that their product acts in the same manner as the innovator drug.   

This is demonstrated by “bioequivalence study” which provides the rate of absorption, or bioavailability, of the generic drug, which is comparable to that of the innovator drug. The generic drug product must deliver the same amount of active ingredient (active component/constituent) into a patient's bloodstream in the same amount of time as the innovator drug.

 

Abbreviated New Drug Application Approval Process

Para I, II, III and IV certifications

ANDA can be filed by following four type of submission. They are listed as:

Paragraph I certification	When patent is not submitted by applicant for drug candidate. When there is no Patent in Orange book. FDA can approve ANDA without delay.
Paragraph II certification	When the existing Patent gets expired. FDA can approve ANDA without delay.
Paragraph III certification	After the certain date when drug patent is going to be expired. FDA can approve ANDA.
Paragraph IV certification	Applicant files the application to FDA for ANDA with paragraph- IV certification. Applicant has to inform the patent holder about this application within 20 days.

NDA and ANDA Requirements

Brand Name Drug NDA Requirements	Generic Drug ANDA Requirements
1.       Chemistry	1.       Chemistry
2.       Manufacturing	2.       Manufacturing
3.       Controls	3.       Controls
4.       Labeling	4.       Labeling
5.       Testing	5.       Testing
6.       Animal Studies	6.       Bioequivalence
7.       Clinical Studies
8.       Bioavailability

Similarity Between NDA and ANDA

Difference Between NDA and ANDA

Table: Difference Between NDA and ANDA

New Drug Application (NDA)	Abbreviated New Drug Application (ANDA)
Application for new drug	Application for generic drug
High investment on drug development	Low investment on drug development
High cost of drug (mean $1336 million)*	Low cost of drug
10-15 years required for drug development	1-2 years required for drug development
Animal Pharmacology and Toxicology studies required	Not required
Complete human pharmacology and clinical efficacy and safety  studies required	Bioavailability and bioequivalence studies required
Patent and exclusivity is granted	No patent, 180 days exclusivity is granted in certain circumstances (first-to-file ANDA)

 * Based on 63 drugs developed by 47 companies between 2009 and 2018. [Reference 3]

Read More: Investigational New Drug Application | IND Application | Types of IND Application

Reference

1. New Drug Application (NDA). Accessed from https://www.fda.gov/drugs/types-applications/new-drug-application-nda.   

2. Abbreviated New Drug Application (ANDA). Accessed from https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda#:~:text=An%20abbreviated%20new%20drug%20application,brand%2Dname%20drug%20it%20references. 

3. Wouters OJ, McKee M, Luyten J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA. 2020 Mar 3;323(9):844-853.