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ANDA-Abbrviated New Drug Application

ABBREVIATED APPLICATIONS

Which products to be included here  ?

n    Drug products that are the same as a listed drug.

n    Drug products that have been declared suitable for an ANDA submission by FDA through citizen petition procedures.

New Product ———– Listed Product

n    In case of any difference, permission is required from FDA to submit an application

n    Person has to submit and obtain approval of a petition requesting the change

n    Petitioner to identify one or more listed drugs

—    Copy of proposed labeling for the drug under petition and

—    Copy of the approved labeling for listed drug

—          Active ingredients to be of the same pharmacological or therapeutic class and

—          New product expected to have same therapeutic effect

—          FDA to approve / disapprove the petition within 90 days.

FDA NOT TO APPROVE A PETITION IF IT FINDS

1.                  Investigations must be conducted (i.e., data is not adequate) to show the safety and effectiveness of the drug product.

2.                  For a petition involving a changed active ingredient, the new drug product is not a combination drug.

3.                  For an entirely different active ingredient petition –

a.                   Information not adequate to evaluate safety and efficacy

b.                  Information not adequate to support labeled claim of pharmacological or therapeutic action

c.                   The different API is not an API in a listed drug

d.                  The remaining APIs are not identical to those of the listed combination drug.

4.                  Any of the proposed changes from the listed drug would jeopardize the safe or effective use of the product.

5.                  FDA comes to know that the reference listed drug has been withdrawn for safety or effectiveness reasons or for unknown reasons.

CONTENTS AND FORMAT OF AN ANDA

Three copies of ANDA required

n    Archival copy

n    Review copy

n    Field copy

ARCHIVAL COPY

1.                  Application form – to state whether submission is an ANDA or a supplement to an ANDA

2.                  Table of contents

3.                  Basis of ANDA – listed drug must be named, otherwise FDA may chose a reference drug on its own.

i.                    Name, dosage form and strength of the reference list drug

ii.                  To state whether the reference listed drug is entitled to a period of marketing exclusivity

iii.                For an ANDA base on an approved petition, reference to FDA-assigned docket number.

4.         Conditions of Use

i.          To state that the conditions of use suggested in the label, have been previously approved for the reference listed drug.

ii.         A reference to the applicant’s annotated proposed labeling and to the currently approved labeling for the reference product.

5.         Active Ingredients

i.          For a single – API product, information to show that an API is the same as that of the reference single – API listed drug.

a.         to state that the API of the proposed drug product is the same as that of the reference listed drug.

b.         a reference to the applicant’s annotated proposed labeling and to the currently approved labeling for the reference listed drug.

ii.         For a combination drug product, information to show that the APIs are the same as those of the reference listed drug, except for any different API that has been the subject of an approved petition :

a.                   A statement that the APIs of the proposed drug product are the same as those of the reference listed drug, or

If one of the APIs differs from one of the APIs of the reference listed drug, and ANDA is submitted under the approval of a petition to vary such API –

Information to show that the other APIs of the drug product are the same as the other active ingredients of the reference listed drug.and

Information to show that the different API is an API of another listed drug.

b.                  a reference to the applicant’s annotated proposed labeling and to the currently approved labeling for the reference listed drug.

6.                  Route of administration, dosage form and strength

Either these should be the same for

Proposed drug product  ——   and  ——— Reference listed drug

If there is a difference

i.                    any difference should be the subject of an approved petition

ii.                  Applicant’s annotated proposed labeling and currently approved labeling for the reference listed drug, to be given, and

iii.                Information about the different route of administration/ strength/dosage form, as required by FDA.

7.         Bioequivalence

i.          Information to show drug product is bioequivalent to the reference listed drug.

ii.         If the ANDA is submitted under a petition, the results of any bioavailability testing – same therapeutic effect to be demonstrated.

If the API in proposed drug product is different than reference listed drug, information to demonstrate –

a.                   substitution of reference listed drug with proposed API will not adversely affect the safety and effectiveness.

b.                  The unchanged APIs in the proposed drug product are bioequivalent to those in the reference listed drug.

c.                   The different API in the proposed drug product is bioequivalent to an approved dosage form containing that ingredient, and approved for the same indication as the proposed drug product.

For each in-vivo bioequivalence study contained in the ANDA, a description of analytical and statistical methods used, and

A statement of compliance with institutional review board regulations,  and

Statement for informed consent.

8.         Labelling

i.          Listed drug labeling – including any medication guide (when the proposed drug product contains an API that is a listed reference product).

ii.         Copies of proposed labeling

4 copies of draft labeling, or

12 copies of final printed labeling.

iii.        Statement on proposed labeling

Statement that proposed labeling is the same as the labeling of the reference listed drug, except for minor differences annotated.

iv.        Comparison of approved and proposed labeling

Proposed labeling  ————-  Side by side comparison ———– Approved labeling for reference listed drug.

Differences may include manufacturer’s name and address, expiry date, formulation, bioavailability or pharmacokinetics, labeling revision or patenting information, etc.

9.         Chemistry, manufacturing and controls

i.          Proposed or actual master production record, along with description of equipments,

ii.         Inactive ingredients – to be identified and characterized, and shown not to affect the safety and efficacy of the proposed drug product.

iii.        For parenteral use – generally the proposed drug product should have same inactive ingredients as the reference listed drug.  Only changes in preservatives, buffers, or antioxidants is allowed, provided information is submitted to show that the differences do not affect the safety or efficacy of the proposed drug product and such new inactive ingredients need to be identified and characterized.

iv.                For ophthalmic or otic use

Same as above

Allowed changes in preservatives, buffer, substances to adjust tonicity, or thickening agent.

Applicant not to claim a therapeutic advantage over or difference from the listed drug.

v.                  For topical use.

Same as above

10.       Samples – to be submitted only when requested by FDA

11.       Other information

12.       Patent certification

13        Financial certification or disclosure statement.

1 responses on "ANDA-Abbrviated New Drug Application"

  1. Keep posting stuff like this i really like it

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