2. An “Abbreviated new drug application”(ANDA) is an application for a U.S. generic drug
approval for an existing licensed medication or approved drug.
The termed as “abbreviated” because they generally not required to include preclinical
(animal) and clinical (human) data to establish safety and effectiveness
An ANDA contains data which is submitted to FDA for the review and potential approval of a
generic drug product. Once approved, an applicant may manufacture and market the generic
drug product to provide a safe, effective, lower cost alternative to the brand-name drug it
references.
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.
Therapeutic Equivalence Evaluations: a drug that has essentially the same effect in the
treatment of a disease as one or more other drugs. All approved products, both innovator and
generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence
Evaluations.
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3. generic product performs in the same way as the innovator drug is to measure the time it takes
the generic drug to reach the bloodstream in healthy volunteers. This demonstration of
“bioequivalence” gives the rate of absorption, or bioavailability, of the generic drug, which
can then be compared to that of the innovator drug.
To be approved by FDA, the generic version must deliver the same amount of active
ingredients into a patient's bloodstream in the same amount of time as the innovator drug.
Basic generic drug requirement are:----
1. Same active ingredient
2. Same route of administration
3. Same dosage form
4. Same strength
5. Same condition of use
6. Inactive ingredient already approved in a similar NDA
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4. A. Signed FDA form 356h: Provides information regarding–
1. The applicants name & address,
2. Name of the drug product,
3. The product strength
4. Route of administration,
5. Indication of drug master files cited,
6. Proposed indications,
7. A statement regarding whether the product is for prescription or over the counter.
B. Index: An index should specify volume & page number for each complete & detailed item.
C. Information: Information on the basis for which the ANDA is being submitted.
a) Name of the reference drug, its dosage form & strength.
b) Information on exclusively for the listed drug.
D. Condition for use, including: a) A statement regarding the condition for which the drug will be used.
b) A reference to a noted labeling for the product & the currently approved labeling for the listed drug
product
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5. Active ingredient :
1. Reference drug: A statement that is the same active ingredient compare with Reference
drug.
2. Combination product: this must be shown for both active ingredients.
Statement: This should include a statement that the route of administration, dosage form &
strength are same as the reference drug.
Bioequivalence: proposed drug is bioequivalent to the listed drug product.
Labeling
Include a copy of currently approved labeling for the listed drug as well as the proposed
labeling for the drug being provided for in the ANDA. A side by side comparison of two sets
of labeling is also necessary.
Chemistry, Manufacturing & Controls: Describe the composition, manufacture,
specifications & analytical procedures for the drug substance & drug product.
1. Human Pharmacokinetics & Bioavailability: This include information concerning
2. The Design
3. The Dosing procedure
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6. Samples: The sample of the Drug substance & finished product should be provided four
individuals units with sufficient quantities in each unit to permit the FDA to perform all the
tests included in the specifications at least three times.
Analytical method for drug substance & drug product: This section should consists of the
specifications, analytical method, certificates of analysis, method of analysis, method
validation & stability indicating data as contained in the chemistry, manufacturing & control
part of the application.
Labeling: 12 specimen of the final printed label & all labeling for the drug product are to be
included.
Case report forms & tabulations: The need for these should be discussed with appropriate
personnel of the division of bioequivalence prior to submission of the ANDA.
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7. To reduce the price of the drug.
To reduce the time development.
Increase the bioavailability of the drug in comparison to references list drug.
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8. Commonly known as “Drug Price Competition & Patent Term Restoration Act” of 1984.
“The Hatch-Waxman Act: is an act dealing with the approval of generic drugs and
associated conditions for getting their approval from FDA, market exclusivity, rights of
exclusivity, patent term extension and Orange Book Listing.”
Established bioequivalence: as the basis for approving generic copies of drug products.
These Amendments permit FDA to approve applications to market generic versions of brand-
name drugs without repeating costly and duplicative clinical trials to establish safety and
efficacy. Under the Hatch-Waxman Amendments, brand-name companies gained patent term
extension to account for the time the patented product is under review by FDA and also
gained certain periods of marketing exclusivity. In addition to the ANDA approval pathway,
generic drug companies gained the ability to challenge patents in court prior to marketing as
well as 180-day generic drug exclusivity.
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9. Guidance documents represent the Agency's current thinking on a particular topic. These
documents provide guidelines for the content, evaluation, and ultimate approval of
applications and also to the design, production, manufacturing, and testing of regulated
products for FDA review staff, applicants, and ANDA holders.
Generic Drugs Guidance's
Biopharmaceutics Guidance's
Product-Specific Guidances for Generic Drug Development
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10. The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the United
States. The law is intended to assure consumers that foods are pure and wholesome, safe to
eat, and produced under sanitary conditions; that drugs and devices are safe and effective for
their intended uses; that cosmetics are safe and made from appropriate ingredients; and that
all labeling and packaging is truthful, informative, and not deceptive.
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