ANDA REQUIREMENTS

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Abbreviated New Drug Application (ANDA)

An application for a license to market a generic (or a

duplicate) version of a drug that has already been granted

an approval under a full NDA.

Generic drug applications are termed "abbreviated"

because they are not required to provide clinical data to

establish safety and efficacy, since these parameters have

already been established.

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According to the FDA, to substitute a generic for a brand name

drug:

■ It must contain the same active ingredients.

■ It must have the same dosage strength (the amount of active

ingredients, for example 20 mg).

■ It must be the same dosage form (that is, it needs to be

available in the same form as the original—for example, as a

liquid, pill, etc.).

■ It must have the same route of administration

■ It must deliver similar amounts of the drug to the bloodstream

(that is, it needs to deliver a comparable amount of the drug into

the bloodstream within a similar time period as the brand name

drug).

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Here’s how generics and brand name drugs differ:

■ They look different

They could have different sizes, shapes, colours.

They have different names.

■ They might have different inactive ingredients.

■ The generic costs less than the brand name drug.

Generics can cost between 20 and 80 percent less.

Different pharmacies carry different generics.

Even the same pharmacy may change generic suppliers.

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Requirements for ANDAs

Must have an approved reference listed drug (RLD)

and a patent certification

Must be Therapeutic Equivalent to a reference product

Meet the quality standards for chemistry and/or

microbiology

All related facilities have acceptable cGMP compliance

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THERAPEUTIC EQUIVALENCE

Pharmaceutically Equivalent (PE)

Same active ingredient(s)

Same dosage form

Same route of administration

Identical in strength or concentration

May differ in characteristics such as shape,

excipients, packaging...

Bioequivalent (BE)

The property in which two drugs with identical active

ingredients have similar bioavailability and produce

same effect at the site of action.

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Use of bioequivalence as the base for approving

generic drug products was established by the "Drug

Price Competition and Patent Term Restoration Act of

1984" also known as the Hatch - Waxman Act.

It is because of this Act that there is the availability of

less costly generic drugs into the market without

conducting costly and duplicative clinical trials.

At the same time, the brand-name companies

(innovators) can apply for up to five additional years

longer patent protection for the new medicines that

they developed to make up the time lost while their

products were going through FDA's approval process.

ANDA requirement

1) Signed form

2) Index

3) Information on the basis of which ANDA submitted

A) Name of reference drug

B) Dosage form

C) Strength

D) Concentration use

4) Statement that the active ingredient is same as that of the reference drug

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5) Route of administration

6) Bioequivalence

7) Label

8) Chemistry, manufacture, control

9) Sample

10) Analytical method

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NDA and ANDA Requirements

Brand Name Drug Generic Drug

NDA Requirements 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

7. Clinical Studies 6. Bioequivalence

8. Bioavailability

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References• Richard A . Gaurino, in „„New drug approval process”,

2nd edition , marcel decckar Inc 270, Newyork .

• “Remington The Science and Practice of Pharmacy”,21th

Edition, volume- 2 ,965-976.

• Kuchekar B. S., in „„Pharmaceutical jurisprudence”,

10th Edition, june 2003 ,Nirali Prakashan.

• Leon lachman, Hebart A. liberman , In “The Theory and

Practice of Industrial Pharmacy” ,3rd edition ,Varghese

Publication House Bombay.

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• www.fda.gov./default.htm

• htpp://en.wikipedia.org/newdrugapplication

• www.fda-mah.com/

• www.sciencedirect.com

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