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By:
      DEBANGSHU S. ROY
      MBA P.M.
      Hamdard University
ANDA
An Abbreviated New Drug Application (ANDA) contains data which when
submitted to FDA's CDER, Office of Generic Drugs, provides for the review
and ultimate approval of a generic drug product.

Once approved, an applicant may manufacture and market the generic
drug product to provide a safe, effective, low cost alternative to the
public.

 All approved products, both innovator and generic, are listed in
FDA's Approved Drug Products with Therapeutic Equivalence
Evaluations (Orange Book).

                                                                            2
INNOVATOR VS GENERICS
S.N. PARAMETERS                              INNOVATOR DRUG GENERIC DRUG
1.    Active ingredients                            Same             Same
2.    Safety & efficacy                             Same             Same
3.    Quality & strength                            Same             Same
4.    Performance and standards                     Same             Same
5.    Costs/prescription                       Highly expensive   Less expensive
6.    FDA inspection of
      manufacturing facilities                       Yes              Yes
7.    FDA reviews reports of
      adverse reactions                              Yes              Yes
8.    FDA reviews drug labeling                      Yes              No
9.    Extensive research and
      development investments                        Yes              No
10.   Expensive marketing &
      advertising                                   Yes              No
11.   Patent protection                             Yes              No
12.   FDA review to show active
      ingredient is equivalent to original            NA             Yes
13.   Product Development Time                    ~ 12 yrs         2- 4 yrs
                                                                                   3
Generic Drug Approval
 In 1970 FDA established the ANDA as a mechanism for the review and
approval of generic versions.

 Before 1978, generic product applicants were required to submit complete
safety and efficacy through clinical trials.

 Post 1978, applicants were required to submit published reports of such
trials documenting safety and efficacy.

Neither of these approaches was considered satisfactory and so originated
Hatch Waxman Act on 1984.


                                                                             4
Indispensability Grounds
                      For Generics
Contain the same active ingredients as the innovator drug (inactive ingredients
may vary).

Must be identical in strength, dosage form, and route of administration.

Must have same use/indications.

Must be bioequivalent.

Must have same batch requirements for Identity, Safety & Purity.

Must follow strict standards of FDA's GMPs.
                                                                                   5
Hatch-Waxman Act

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.”

Necessitated By :

1. Absence of Generic drug manufacturing.

2. Cumbersome regulatory procedures.

3. Patients were denied the option of cheaper drugs.
                                                                                      6
General Provisions of the Act


1. Maintaining list of patents which would be infringed.

2. Only Bioavailability studies and not clinical trials needed for approval.

3. Para I, II, III and IV certifications.

4. Data exclusivity period for New Molecular Entities.

5. Extension of the original patent term.

6. The “Bolar” Provision.
                                                                               7
Recent additions to the Hatch-Waxman
                  Act
Under the “Medicare Prescription Drug and Modernization Act”, 2003:

1. Non-extension of the 30-month period.

2. Time limit for informing patent owner.

3. Provision for allowing declaratory judgment.

4. Benefit of exclusivity for several ANDAs filed on same day allowed.

                                                                         8
ANDA CERTIFICATION CLAUSES




                          PARAGRAPH   PARAGRAPH
PARAGRAPH I   PARAGRAPH                   IV
                  II          III



                                                  9
PARA-I                 PARA-II
   Required patent
 information has not     Patent has expired
      been filed.


  FDA may approve         FDA may approve
generics immediately,   generics immediately,
     one or more             one or more
applicants may enter.   applicants may enter.

                                                10
PARA-III                   PARA-IV
Patent not expired, will    Patent is invalid or non
be expired on a specific     infringed by generic
         date.                     applicant.



FDA may approved ANDA
 effective on the date of    Generic applicant file
expiration, one or more     notice to patent holder.
  applicant may enter.


                                                       11
PARA IV CERTTIFICATION




                                                            After 45 days Patent
After 45 days Patent
                                                               Holder sues the
 Holder doesn’t sue
                                                           Applicant 30months
applicant FDA may
                                                           stay granted to Patent
   approve ANDA.
                                                                   Holder.




ANDA Applicant granted
                                           30 Months stay expired             30 Months stay not
      approval.
                                                                                   expired.




                          For the first Applicant           Subsequent approvals
                           the EMR of 180 days              for EMRs are granted
                            starts with court’s              after expiry of first
                                 decision.                   applicant’s 180 days.
                                                                                                   12
30 Months stay not
                         expired




If judgement’s in favour            Judgement favouring
of Patent Holder FDA                ANDA EMR of 180
 can not approve ANDA               days begins for first
   untill patent expiry.                 applicant.




                                   First Applicant enters,
                                   subsequent applicants
 No entry occurs untill
                                  enter only after expiry of
     Patent Expiry.
                                      EMR for the First
                                          Applicant.
                                                               13
ANDA REVIEW PROCESS
                                       APPLICANT


                                                ANDA

                                             ACCEPTABLE &                     REFUSE TO FILE-
                                              COMPLETE           NO           LETTER ISSUED

                                                    YES
                  B.E. REVIEW                               CHEMISTRY/MICRO
                                                                REVIEW

                REQUEST FOR PLANT
                   INSPECTION                                 LABELING REVIEW


                                                               CHEMISTRY/LABELING
                    B.E. REVIEW ACCEPTABLE
                                                 YES           REVIEW ACCEPTABLE
                                                                                                NO
           NO
                                     PREAPPROVAL INSPECTION                          NOT APPLICABLE
                                          ACCEPTENCE
                                                                        NO               LETTER
B.E. DEFICIENCY LETTER

                                              YES                     APPROVAL DEFERRED PENDING
                                                                         SATISFACTORY RESULTS


                                       ANDA APPROVED
                                                                                                      14
The CTD Triangle

                     Regional
                      Admin.
                   Information
                  MODULE 1


                   Non Clinical Clinical
        Quality      overview Overview
        Overall    Non Clinical   Clinical
       summary      Summary     Summary


    Quality       Non Clinical      Clinical
                    Report          Report

MODULE 3           MODULE 4          MODULE 5
                                                15
MODULES IN A CTD

MODULE I: Administrative and Prescribing Information

1.Table of Contents.

2.Includes data of Administrative Documents entailing:
Patent Information on patented product.
Patent Certifications.
Debarment certification.

3. Prescribing information like Package and container labels, packaging inserts,
patient leaflets, etc.

4. Labelling Comparison between Innovator and Generic drug.


                                                                                   16
MODULE II: SUMMARIES AND OVERVIEWS
1. Table of Contents.

2. Introduction to Summary Documents.

3. Overviews and Summaries: Module II should contain documents like:
     M4Q: The CTD- quality
     M4S: The CTD- safety
     M4E: The CTD- efficacy
MODULE III: information on product quality
   1.   Table of Content.

   2. Body of Data.

   3. Literature Reference.
                                                                       17
MODULE IV: NON CLINICAL STUDY REPORTS

Not required in ANDA Filing.



MODULE V: CLINICAL STUDY REPORTS

1. Table of Contents.

2. Study Reports including Case Report Forms and Case Report Tabulations.




                                                                            18
RECOMMENDATIONS FOR e-CTD

1.   PDF Files with version 3.0 of Acrobat Reader

2. Use of Embedded fonts in the Portable Document Format

3. A Print area of 8.5 inches by 11 inches and margin of 1 inches is ensured on
   sides.

4. Scanned Documents should be avoided as Source Documents.

5. Hypertexts can be indicated by Blue-Texts or by rectangles using thin lines.



                                                                                  19
6. Numbering on the PDF and Documents should be included as same.


7. Security or Passwords should not be included.


8. Full Indexes should be included.


9. Electronic Signatures may be added, Procedures are being employed for
archival of the same.



                                                                           20
BIOEQUIVALENCE
A Generic drug is considered to be bioequivalent to Brand drug if:

Rate & extent of absorption do not show a significant difference from RLD.

Two drugs are said to be Bioequivalent if their Bioavailability after
administration in same dose are similar to a degree that there effects, with
respect to safety & efficacy can be expected to be the same.




                                                                               21
NDA Vs ANDA Review Process

NDA REQUIREMENT    ANDA REQUIREMENT




                                      22
First-Time Generic Drug
                Approvals - July 2011
Generic Drug          Generic                Brand Name            Approval Date
Name                  Manufacturer
FONDAPARINUX SODIUM   DR. REDDY'S            ARIXTRA INJECTION     7/11/2011
INJECTION             LABORATORIES LIMITED
ALFUZOSIN             TEVA                UROXATRAL EXTENDED-      7/18/2011
HYDROCHLORIDE         PHARMACEUTICALS USA RELEASE TABLETS
EXTENDED-RELEASE
TABLETS
ALFUZOSIN             SUN PHARMA GLOBAL      UROXATRAL EXTENDED-   7/18/2011
HYDROCHLORIDE         FZE                    RELEASE TABLETS
EXTENDED-RELEASE
TABLETS
PARICALCITOL          SANDOZ CANADA, INC.    ZEMPLAR INJECTION     7/27/2011
INJECTION
METRONIDAZOLE GEL     TOLMAR INC.            METROGEL              7/22/2011
                                                                                   23
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THANK YOU
            40

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ANDA filing

  • 1. By: DEBANGSHU S. ROY MBA P.M. Hamdard University
  • 2. ANDA An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public.  All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). 2
  • 3. INNOVATOR VS GENERICS S.N. PARAMETERS INNOVATOR DRUG GENERIC DRUG 1. Active ingredients Same Same 2. Safety & efficacy Same Same 3. Quality & strength Same Same 4. Performance and standards Same Same 5. Costs/prescription Highly expensive Less expensive 6. FDA inspection of manufacturing facilities Yes Yes 7. FDA reviews reports of adverse reactions Yes Yes 8. FDA reviews drug labeling Yes No 9. Extensive research and development investments Yes No 10. Expensive marketing & advertising Yes No 11. Patent protection Yes No 12. FDA review to show active ingredient is equivalent to original NA Yes 13. Product Development Time ~ 12 yrs 2- 4 yrs 3
  • 4. Generic Drug Approval  In 1970 FDA established the ANDA as a mechanism for the review and approval of generic versions.  Before 1978, generic product applicants were required to submit complete safety and efficacy through clinical trials.  Post 1978, applicants were required to submit published reports of such trials documenting safety and efficacy. Neither of these approaches was considered satisfactory and so originated Hatch Waxman Act on 1984. 4
  • 5. Indispensability Grounds For Generics Contain the same active ingredients as the innovator drug (inactive ingredients may vary). Must be identical in strength, dosage form, and route of administration. Must have same use/indications. Must be bioequivalent. Must have same batch requirements for Identity, Safety & Purity. Must follow strict standards of FDA's GMPs. 5
  • 6. Hatch-Waxman Act 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.” Necessitated By : 1. Absence of Generic drug manufacturing. 2. Cumbersome regulatory procedures. 3. Patients were denied the option of cheaper drugs. 6
  • 7. General Provisions of the Act 1. Maintaining list of patents which would be infringed. 2. Only Bioavailability studies and not clinical trials needed for approval. 3. Para I, II, III and IV certifications. 4. Data exclusivity period for New Molecular Entities. 5. Extension of the original patent term. 6. The “Bolar” Provision. 7
  • 8. Recent additions to the Hatch-Waxman Act Under the “Medicare Prescription Drug and Modernization Act”, 2003: 1. Non-extension of the 30-month period. 2. Time limit for informing patent owner. 3. Provision for allowing declaratory judgment. 4. Benefit of exclusivity for several ANDAs filed on same day allowed. 8
  • 9. ANDA CERTIFICATION CLAUSES PARAGRAPH PARAGRAPH PARAGRAPH I PARAGRAPH IV II III 9
  • 10. PARA-I PARA-II Required patent information has not Patent has expired been filed. FDA may approve FDA may approve generics immediately, generics immediately, one or more one or more applicants may enter. applicants may enter. 10
  • 11. PARA-III PARA-IV Patent not expired, will Patent is invalid or non be expired on a specific infringed by generic date. applicant. FDA may approved ANDA effective on the date of Generic applicant file expiration, one or more notice to patent holder. applicant may enter. 11
  • 12. PARA IV CERTTIFICATION After 45 days Patent After 45 days Patent Holder sues the Holder doesn’t sue Applicant 30months applicant FDA may stay granted to Patent approve ANDA. Holder. ANDA Applicant granted 30 Months stay expired 30 Months stay not approval. expired. For the first Applicant Subsequent approvals the EMR of 180 days for EMRs are granted starts with court’s after expiry of first decision. applicant’s 180 days. 12
  • 13. 30 Months stay not expired If judgement’s in favour Judgement favouring of Patent Holder FDA ANDA EMR of 180 can not approve ANDA days begins for first untill patent expiry. applicant. First Applicant enters, subsequent applicants No entry occurs untill enter only after expiry of Patent Expiry. EMR for the First Applicant. 13
  • 14. ANDA REVIEW PROCESS APPLICANT ANDA ACCEPTABLE & REFUSE TO FILE- COMPLETE NO LETTER ISSUED YES B.E. REVIEW CHEMISTRY/MICRO REVIEW REQUEST FOR PLANT INSPECTION LABELING REVIEW CHEMISTRY/LABELING B.E. REVIEW ACCEPTABLE YES REVIEW ACCEPTABLE NO NO PREAPPROVAL INSPECTION NOT APPLICABLE ACCEPTENCE NO LETTER B.E. DEFICIENCY LETTER YES APPROVAL DEFERRED PENDING SATISFACTORY RESULTS ANDA APPROVED 14
  • 15. The CTD Triangle Regional Admin. Information MODULE 1 Non Clinical Clinical Quality overview Overview Overall Non Clinical Clinical summary Summary Summary Quality Non Clinical Clinical Report Report MODULE 3 MODULE 4 MODULE 5 15
  • 16. MODULES IN A CTD MODULE I: Administrative and Prescribing Information 1.Table of Contents. 2.Includes data of Administrative Documents entailing: Patent Information on patented product. Patent Certifications. Debarment certification. 3. Prescribing information like Package and container labels, packaging inserts, patient leaflets, etc. 4. Labelling Comparison between Innovator and Generic drug. 16
  • 17. MODULE II: SUMMARIES AND OVERVIEWS 1. Table of Contents. 2. Introduction to Summary Documents. 3. Overviews and Summaries: Module II should contain documents like:  M4Q: The CTD- quality  M4S: The CTD- safety  M4E: The CTD- efficacy MODULE III: information on product quality 1. Table of Content. 2. Body of Data. 3. Literature Reference. 17
  • 18. MODULE IV: NON CLINICAL STUDY REPORTS Not required in ANDA Filing. MODULE V: CLINICAL STUDY REPORTS 1. Table of Contents. 2. Study Reports including Case Report Forms and Case Report Tabulations. 18
  • 19. RECOMMENDATIONS FOR e-CTD 1. PDF Files with version 3.0 of Acrobat Reader 2. Use of Embedded fonts in the Portable Document Format 3. A Print area of 8.5 inches by 11 inches and margin of 1 inches is ensured on sides. 4. Scanned Documents should be avoided as Source Documents. 5. Hypertexts can be indicated by Blue-Texts or by rectangles using thin lines. 19
  • 20. 6. Numbering on the PDF and Documents should be included as same. 7. Security or Passwords should not be included. 8. Full Indexes should be included. 9. Electronic Signatures may be added, Procedures are being employed for archival of the same. 20
  • 21. BIOEQUIVALENCE A Generic drug is considered to be bioequivalent to Brand drug if: Rate & extent of absorption do not show a significant difference from RLD. Two drugs are said to be Bioequivalent if their Bioavailability after administration in same dose are similar to a degree that there effects, with respect to safety & efficacy can be expected to be the same. 21
  • 22. NDA Vs ANDA Review Process NDA REQUIREMENT ANDA REQUIREMENT 22
  • 23. First-Time Generic Drug Approvals - July 2011 Generic Drug Generic Brand Name Approval Date Name Manufacturer FONDAPARINUX SODIUM DR. REDDY'S ARIXTRA INJECTION 7/11/2011 INJECTION LABORATORIES LIMITED ALFUZOSIN TEVA UROXATRAL EXTENDED- 7/18/2011 HYDROCHLORIDE PHARMACEUTICALS USA RELEASE TABLETS EXTENDED-RELEASE TABLETS ALFUZOSIN SUN PHARMA GLOBAL UROXATRAL EXTENDED- 7/18/2011 HYDROCHLORIDE FZE RELEASE TABLETS EXTENDED-RELEASE TABLETS PARICALCITOL SANDOZ CANADA, INC. ZEMPLAR INJECTION 7/27/2011 INJECTION METRONIDAZOLE GEL TOLMAR INC. METROGEL 7/22/2011 23
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  • 40. THANK YOU 40

Editor's Notes

  1. Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug).  One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.  This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug.  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.