NEW DRUG APPLICATION AND ABBREVIATED NEW DRUG APPLICATION

1. NDA AND ANDA
PRESENTED BY ,
ANU TREESA THOMAS
1ST MPHARM
ST J0SEPH COLLEGE OF PHARMACY
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2. CONTENTS
● Introduction
● NDA
● NDA classifications
● NDA contents
● Steps involved in NDA
● ANDA
● NDA vs ANDA review process
● ANDA steps
● Conclusion
● References
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3. INTRODUCTION
● When the sponsor of a new drug believes that
enough evidence on the drug’s safety and
effectiveness has been obtained to meet FDA
requirement ,then they submit a new drug
application.
● Abbreviated new drug application contains data
that when submitted to FDA ,provides for the
review and ultimate approval of a generic drug
product.
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4. NDA(NEW DRUG APPLICATION)
● It is the vehicle through which the drug sponsors
formally propose FDA or DCGI to approve a new
investigational drug for sale and marketing after
phase 3 pivot trials.
● The official definition of New Drug is in Sec 201(p)
of Federal Drug,Food and Cosmetics Act; Any new
drug, the composition of which is such that it is not
recognized among experts qualified by scientific
training as safe and effective for use under
prescribed,recommended or suggested conditions.
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5. ❖ It is the critical component for drug approval
process which is required to submit to USFDA
before drug commercialization.
❖ The data gathered during the animal studies and
human clinical trials of an Investigational New Drug
(IND) become part of NDA.
❖ GOAL
The NDA provide enough information to permit FDA
reviewer to reach safety ,efficacy and quality for
pharmaceutical production.
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6. NDA CLASSIFICATIONS
⮚ New molecular entity.
⮚ New salt of previously approved drug.
⮚ New formulation of previously approved drug.(not a
new salt OR a new molecular entity)
⮚ New combination of two or more drugs.
⮚ Already marketed drug product –
Duplication(i.e.,new manufacturer)
⮚ New indication(claim) for already marketed
drug(includes switch in marketing status from
prescription to OTC)
⮚ Already marketed drug product- No previously
approved NDA.
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7. NDA CONTENTS
● Section 1: Overall NDA index
The NDA index is a comprehensive table of
contents that enables the reviewers to find specific
information in this massive document quickly.
● Section 2 : Labelling
It must include all draft labelling that is intended
for use on the product container ,cartons or
packages ,including the proposed package inserts.
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8. ● Section 3 : Application summary
▪ Proposed annotated package insert.
▪ Pharmacology class , scientific rational , intended
use , and potential clinical benefits.
▪ Foreign marketing history.
▪ Chemistry , manufacturing and control summary.
▪ Nonclinical pharmacology and toxicology summary.
▪ Human pharmacokinetics and bioavailability
summary.
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9. ● Section 4 :Chemistry , manufacturing and controls
▪ Chemistry , manufacturing and control information
▪ Samples
▪ Methods validation package
● Section 5: Non clinical pharmacology and toxicology
▪ Provide individual study reports , including pharmacology
, toxicology , ADME studies.
▪ Interactions with other drugs.
▪ Effects related to the therapeutic indication ,such as
the pharmacodynamic ED50 in dose- ranging studies and
the mechanism of action.
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10. ● Section 6:Human pharmacokinetics and
bioavailability
▪ Includes data from Phase 1 safety and tolerance
studies in healthy volunteers.
▪ Summary of analytical method used in invivo
biopharmaceutics study.
▪ Pilot or background studies.
▪ Bioavailability or bioequivalence studies.
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11. ● Section 7 :Microbiology
Requires the following technical information and data,
▪ A complete description of the biochemical basis of
the drug action on microbial physiology.
▪ The drugs antimicrobial spectrum.
▪ Clinical microbiology laboratory methods.
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12. ● Section 8:Clinical data
Includes,
▪ List of investigators and list of IND and NDAs
▪ Background or overview of clinical investigations
▪ Clinical pharmacology
▪ Controlled clinical trials
▪ Integrated summary of effectiveness data
▪ Integrated summary of safety information
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13. ▪ Section 9:Safety data
▪ Statements In draft labelling.
▪ Contraindications
▪ Warnings
▪ Precautions
▪ Adverse events
● Section 10: Statistical data
▪ All controlled clinical trial reports
▪ Integrated efficiency and safety reports
▪ Integrated summary of risks and benefits
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14. ● Section 11 :Case report tabulations
● Section 12 :Case report forms
● Patent information
● Patent certification
● Other information
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15. STEPS INVOLVED IN NDA
Receipt of NDA application
CDER stamps the application with a receipt date
FDA assigns the application for review
If the application is incomplete , then FDA has to
inform to the applicant
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16. If complete sends it for secondary review process
FDA inspects manufacturing facilities of the drug
Once all reviews are complete , the Divisional Director
evaluates the reviews and make FDA’s decision.
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17. ANDA
● An abbreviated new drug application contains data which is
submitted to FDA for the review and the potential approval
of 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.
● It termed abbreviated because they generally not required
to include preclinical & clinical data to establish safety and
effectiveness.
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18. ● Generic applicants must scientifically
demonstrate that their product performs in the
same manner as the innovator drug by measuring
the time it takes to reach in the bloodstream in
healthy volunteers.
● This demonstration of “bioequivalence” gives the
rate of absorption or bioavailability of the
generic drug which can be then compared to the
innovator drug.
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19. Basic generic drug requirements are:
✔ Same active ingredients
✔ Same route of administration
✔ Same dosage form
✔ Same strength
✔ Same conditions of use
✔ Inactive ingredients already approved in a similar
NDA.
GOALS
❑ To reduce the price of drug.
❑ To reduce the development time.
❑ Increase the bioavailability of drug in comparison to
reference list drug.
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20. NDA vs. ANDA review process
● NDA requirement
o Labelling
o Pharmacology
&Toxicology
o Chemistry
o Manufacturing
o Controls
o Microbiology
o Inspection
o Testing
o Animal studies
o Human studies
● ANDA requirement
o Labelling
o Pharmacology
&Toxicology
o Chemistry
o Manufacturing
o Controls
o Microbiology
o Inspection
o Testing
o Bioequivalence
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21. ANDA STEPS
⮚ Filling review
⮚ Co ordination of generic drug review process
⮚ Bioequivalence review process
⮚ Chemistry review process
⮚ Labelling review process
⮚ Putting it all together
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22. ● Filling review
The process begins when as applicant submits an
ANDA to the
OGD(Office of Generic Drugs)
The staff assigns it an ANDA number and stamps a
received date on the cover letter of ANDA.
It is sent to a consumer safety technician who reviews
the preliminary sections of ANDA checklist.
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23. Within first 60 days of submission, filling review is completed.
Regulatory Support Branch (RBS)is responsible for this process.
RPM compares the contents of each section against a list of
regulatory requirements.
If the application contains all An applicant may not
necessary regulatory receive letter when an inactive
requirements ,an ingredient level exceeds the
‘acknowledgment’ letter is level previously used in an
Issued to the applicant indicating approved drug product via the
Its acceptance for filling. same route of administration.
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24. Upon filling an ANDA , the RPM
(Review Process Manager) forwads
An Establishment Evaluation Request
(EER) to the office of compliance.
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25. ❑ Co ordination of the generic drug review process
▪ The application enters the review queue,means that
the application is assigned to a bioequivalence
reviewer , a chemist and a labelling reviewer.
▪ The chemistry project manager serves as the
“Applicant “ project manager(APM).
▪ They plan , organize and co ordinate all review
activities for the applicaions they manage.
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26. ❑ Bioequivalence review
Bioequivalence review process established that the proposed
generic drug is bioequivalent to the reference listed drug,
based upon a demonstration that both the rate & extent of
absorption of the active ingredient of the generic drug fall
within established parameters when compared to that of the
reference listed drug.
❑ Chemistry/Microbiology review
This process provides assurance that the generic drug will be
manufactured in a reproducible manner.
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27. ❑ Labelling review
This process ensures that the proposed generic drug
labelling is identical to that of the reference listed
drug.
❑ Putting it all together
After the final review and individual disciplines have
resolved their deficiencies ,the application will either
receive a full approval or a tentative letter.
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28. DIFFERENCES
NDA ANDA
▪ Applicable for new drug ▪ Applicable for generic drug
▪ Take longer time (12 – 15
years)
▪ Compare to NDA less time
is taken(1- 2 years)
▪ More expenditure of
money
▪ Comparatively less
▪ Cost of drugs are more ▪ Cost of drugs are less
▪ Nonclinical studies and
clinical investigations are
essential
▪ Nonclinical studies and
clinical investigations are
nonessential except
bioavailability and
bioequivalence
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29. CONCLUSION
● NDA is applicable for a new drug whereas ANDA
is for a generic drug
● This is a necessary procedure before the
marketing of a drug product.
● Bioequivalence is measured in case of ANDA
whereas clinical trials are necessary in NDA.
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30. REFERENCES
● J.P.Douglas,S.M,David.FDA regulatory affairs,A
guide for prescription drugs,medical devices and
biologics.2nd edition.Marcel Dekker,inc.p.69-108.
● V.A.Loyd,G.P.Nicholas,C .Howard.Ansel’s
pharmaceutical dosage forms and delivery
systems.8th edition.Bpublication.p.25-65.
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31. THANK YOU…
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