ANDA REQUIREMENTS
1
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.
2
3
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).
4
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.
5
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
6
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.
7
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
8
5) Route of administration
6) Bioequivalence
7) Label
8) Chemistry, manufacture, control
9) Sample
10) Analytical method
9
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
10
11
12
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.
13
• www.fda.gov./default.htm
• htpp://en.wikipedia.org/newdrugapplication
• www.fda-mah.com/
• www.sciencedirect.com
14
15