ANDA Abbreviated New

Drug Application
BY
N.NARESH KUMAR
m.pharm(cology)

Definition of ANDA:

AN abbreviated new drug application (ANDA) is an

application for a US generic drug approval for an existing
licensed medication or approved drug.

Definition of generic drug :

A generic drug product is one that is comparable to an
innovator drug product in dosage form, strength, route of
administration, quality, performance characteristics and
intended use.
All approved products, both innovator and generic, are listed
in FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations (Orange Book).

-Genetic drugs always been available in US market

DESI: drug efficacy study implementation.

When the desi program was in progress, the agency estimated that
there were between 5-13 products without NDAs that were
identical and similar to each of the 13,000 products that held
NDAs under the 1938 act

These products contain same active ingredients in the same

amount and dosage form, often though they claim some unique
characteristics i.e: a different salt or ester, different amount, a
different dosage form or an extra added ingredients.

Evolution of ANDA:
CHF

patients who had been treated carefully with a specific dose

of digoxin, went out of control upon getting prescriptions refilled

Investigations

revealed that digoxin, never subject to an NDA,

varied from manufacturer to manufacturer not in quantity of actual
drug per tablet , but in the amount of drug released from the tablet
into the body

The

consequences could be life threatening

 the

agency responded with an order that each manufacturer

submit an ANDA that included bioavailability studies showing the
rate and extent of absorption into the body

The ANDA process

and bioequivalence studies permitted the

individual generic products to be therapeutically equivalent to
approved brand drug

 ANDA

Generics:

An ANDA

contains data which when submitted to FDAs centre

for drug evaluation and research , office of of generic drugs,
provides for the review and ultimate approval of a generic drug
product

Once

approved an applicant may mfg and market the generic

drug product drug to provide a safe, efficant, low cost alt to the
American public

 A generic

drug product is one that is Comparable to

an innovator drug product in dosage form, strength,
route of administration, quality and performance
characteristics

Generic

applicants must scientifically demonstrate

that their product is bioequivalance

 One

way to demonstrate bioequivalance is to measure

the time it takes the generic drug to reach the blood
stream in 24 to 36 hrs In a healthy volunteer

This

gives the rate of absorption or bioavailability of

generic drug which they can compare to the innovator
drug

Why it is abbreviated ?
the

term abbreviated is used in generic drug applications

because these applications does not require preclinical
and clinical data to establish safety and efficacy

Scientific

demonstration of the bioequivalance is

important and must

Necessary items of ANDA

The

composition of drug stating the name and amount of

each ingredient whether active or not, contained in a stated
quantity of the drug

Identify

the place where the drug is manufactured,

processed, packaged, Labeled and the name of the
supplier of the active ingredient

Identify

any person other than the applicant who performs a

part of those operations

 include

certifications from the applicant and the methods

used in the process and the facilities and controls used for
mfg, processing, packing, labeling in conformity with the
current GMP

assure

that the drug dosage form and components comply

with the specifications and tests described in an official
compendium

if

the drug differs from the compendium drug, the

specifications and tests applied to the drug and its
components are adequate to assure their identity, strength,
quality and quantity

 Outline

the methods used in and the facility and

control used for mfg, processing, and packaging of the
drug

If

the drug require only an ANDA also specifies that

there must be included adequate data to assure the
bioavailability of the drug

goal of ANDA:
to

reduce the price of the drug

to

reduce the time development

increase

the bioavailability of the drug in

comparison to reference list drug

WAXMAN- HATCH ACT:

using

the bioequivalance as the basis for approving

generic copies of products was established by the
drug price commission and patent term restoration act
of 1984, is known as Waxman - hatch act

this

act expedites the availability of less costly generic

drugs by permitting FDA to approve application to
market generic versions of brand names without
conduct costly clinical trials

 Also

it provides mechanism to grant drug companies

upto 5 years additional patent protection to
compensate the patent life lost as a result of the time
consumed during test required by FDA

Conditions which must be fulfilled in order to ask an

extension are :
Patent

must not have expired at the time of filing the request

for extension

The

product must have been subjected to examination by

FDA

The

request for extension must have been filed within 60

days of the granting of FDA

 the

request for extension must have been filed at the

latest during the last three months of the life of the
patent

A fee

of $750 is paid

NDA vs ANDA review process:

NDA requirements
1.Labelling
2.Pharm/tox
3.Chemistry
4.Manufacturing
5.Controls
6.Microbiology
7.Inspection
8.Testing
9.Animal studies
10.Clinical studies
11.bioavailability

ANDA requirements
1. Labelling
2.Pharm/tox
3.Chemistry
4.Manufacturing
5.Controls
6.Microbiology
7.Inspection
8.Testing
9.bioequivalence

Labelling:
o

Same information as brand name labelling

May differ in excipients and product description (color,

shapes)

Pharm/tox:
o

All inactive ingredients must be approved in either the

reference list or similar NDA in same or higher levels

Chemistry, manufacturing and controls:

o
o
o
o
o
o

Components and composition

Mfg and controls
Batch formulation and records
Description of facilities
Packaging
Stability

Microbiology:

Includes for anti infective drug compounds

A complete description of the biochemical basis of
drug action on microbial physiiology

Clinical microbiology laboratory methods

Assure the sterility of products especially with

injectibles

Inspection/testing :
o

Assure mfg facilities are in compliance with current

GMPS

assure bioequivalance sites are in compliance with

good clinical practices (cGCPS)

Bioequivalance:
A generic

drug is considered to be bioequivalent to

the brand name drug if:

-The rate and extent of absorption do not show a

significant difference from listed drug