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Presented By,
K. Trideva Sastri
M.Pharm 1 Semester (Pharmaceutics)
Reg No. 121727101005
ABBREVIATED NEW DRUG
APPLICATION (ANDA)
• The Food and Drug Administration (FDA) is
organized into eight centers,
Introduction
Sno. Name of the Center Abbreviation
1 The Center For Drug Evaluation And Research CDER
2 The Center For Biologics Evaluation And Research CBER
3 The Center For Devices And Radiological Health CDRH
4 The Center For Food Safety And Applied Nutrition CFSAN
5 The Center For Veterinary Medicine CVM
6 The National Center For Toxicological Research NCTR
7 The Office Of The Commissioner OC
8 The Office Of Regulatory Affairs ORA
The CDER reviews the safety and Efficacy of drug products.
The Center Director oversees 11 offices which include,
• The Office of Pharmaceutical Science,
• The Office of New Drugs,
• The Office of Executive Programs,
• The Office of Pharmacoepidemiology and Statistical
Science,
• The Office of Management,
• The Office of Regulatory Policy,
• The Office of Medical Policy,
• The Office of Counter-Terrorism and Pediatric Drug
Development,
• The Office of Training and Communications,
• The Office of Compliance,
• The Office of Information Technology
• Organizationally, the Office of Generic Drugs
(OGD) is located within the CDER under the
Office of Pharmaceutical Science. It consists
of the following divisions:
• Chemistry,
• Bioequivalence, and
• Labeling and Program Support
• The Hatch-Waxman Act (HWA) to the Federal
Food, Drug and Cosmetic Act (FD&C) gave
clear statutory authority to submit Abbreviated
New Drug Applications (ANDAs) for all
approved innovator drugs.
• With the passage of the HWA, who sought to
market a generic version of a drug were not
required to repeat the costly preclinical and
clinical testing associated with a New Drug
Application (NDA).
• The OGD had its origins in the early 1970s
and was known as the office of Drug
Monographs. After the passage of the HWA in
1984, the office of Drug Monographs became
the office of Drug Standards.
• The Office of Drug Standards contained the
Division of Generic Drugs (DGD) and the Division
of Bioequivalence.
• The OGD as we know it today was established in
1990 as part of the Office of Pharmaceutical
Science (OPS).
• Its mission is to ensure that safe and effective
generic drugs are available for the American people.
• The OGD ensures the safety and efficacy of generic
drugs by employing a review process that is similar
to the NDA process.
• The primary difference between the Generic Drug
Review process and the NDA review process is
the study requirements.
 For example, an ANDA generally requires
a bio equivalence study between the
generic product and the reference listed drug
(RLD) product.
• The safety and efficacy of the RLD product were
established previously through animal studies,
clinical studies and bioavailability studies. Thus,
these studies need not be repeated for the ANDA.
• Generic drug applications are termed
“abbreviated” because they are generally not
required to include preclinical (animal) &
clinical (human) data to establish safety &
effectiveness.
• A generic drug product is one that is
comparable to an innovator drug product in
dosage form, strength, route of
administration, quality, performance
characteristics & intended use.
• All approved products, both innovator &
generic, are listed in FDA’s Approved Drug
Products with Therapeutic Equivalence
Evaluations.
• Generic applicants must scientifically
demonstrate that their product is
bioequivalent (i.e. performs in the same
manner as the innovator drug).
• The rate of absorption or bioavailability of
the generic drug, is compared 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 as that in the
innovator drug.
• Using bioequivalence as the basis for
approving generic copies of the drug products
was established by the “Drug Price Competition
& Patent Term Restoration Act of 1984”, also
known as the Waxman-Hatch Act.
• Generic drug application reviewers focus on
bioequivalence data, chemistry &microbiology
data, request for plant inspection, & drug
labeling information.
Indispensability Ground 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.
ANDA REQUIREMENT
• Signed FDA form 356h.
• Provides information regarding
• The applicants name & address, name of the
drug product, the product strength & route of
administration, indication of drug master files
cited, proposed indications, a statement regarding
whether the product is for prescription or over the
counter.
• An index should specify volume & page number
for each complete & detailed item.
• 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.
c) If a suitability petition is approved a
reference to the FDA number that was
assigned to that suitability petition.
• Condition for use, including,
a) A statement regarding the condition for which
the drug will be used.
b) A reference to the annoted labeling for the
product & the currently approved labeling for the
listed drug product.
• A statement that active ingredient is the same
as for that of the reference drug. For the
combination product this must be shown for
both active ingredient.
• Route of administration, dosage form &
strength. This should include a statement that
the route of administration, dosage form &
strength are same as the reference drug.
• Bioequivalence. This should include
information to demonstrate that the 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.
• Human Pharmacokinetics & Bioavailability.
This include information concerning
• The Design
• The Dosing procedure
• The number & frequency of blood & urine collection &
Methodology for the assay.
• 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.
ANDA
CERTIFICATION
CLAUSES
PARAG-
RAPH I
PARAG-
RAPH II
PARAG-
RAPH III
PARAG-
RAPH IV
When applicant submit ANDA to FDA, the applicant must
Certify one of four things under section 505(j)(2)(A)(VII)
PARA-I
Required patent
information has
not been filed.
FDA may approve
generics
immediately, one
or more applicants
may enter.
PARA-II
Patent has expired
FDA may approve
generics
immediately, one
or more applicants
may enter.
22
PARA-III
Patent not expired,
will be expired on a
specific date.
FDA may approved
ANDA effective on
the date of
expiration, one or
more applicant may
enter.
PARA-IV
Patent is invalid or
non infringed by
generic applicant.
Generic applicant file
notice to patent
holder.
23
PARA IV
CERTTIFICATION
After 45 days
Patent Holder
doesn’t sue
applicant ►
FDA may
approve ANDA.
ANDA
Applicant
granted
approval.
After 45 days
Patent Holder
sues the
Applicant ►
30months stay
granted to
Patent Holder.
30 Months
stay expired
For the first
Applicant the
EMR of 180
days starts with
court’s
decision.
Subsequent
approvals for
EMRs are
granted after
expiry of first
applicant’s 180
days.
30 Months
stay not
expired.
DETAILS NDA ANDA IND
1.Chemistry,manufacturing,
and controls
yes Yes Yes
2.Nonclinical pharmacology
and toxicology (Animal
data)
Yes No Yes
3. Human pharmacokinetics
and bioavailability
Yes Yes No
4. Microbiology Yes Yes No
5.Clinical data Yes
Yes
(BABE studies)
No
6.Statistical Yes Yes Yes
ANDA
(Reviewed by CDER)
Applicant
• An applicant means any person (usually a
pharmaceutical firm) who submits an
abbreviated new drug application, or an
amendment or supplement to them, to obtain
FDA approval to market a generic drug
product.
Acceptable & Complete?
• An application must contain sufficient
information to allow a review to be conducted in
an efficient & timely manner.
• Upon receipt of the application a pre-filling
assessment of its completeness & acceptability
is performed by a project manager within the
regulatory support branch, Office of Generic
Drugs.
• If this initial review documents that the applicant
contains all the necessary components, an
“acknowledgment letter” is sent to the applicant.
Refuse to file letter issued
• If the application is missing one or more
essential components, a “Refuse to File” letter
is sent to the applicant.
• No further review of the application occurs
until the applicant provides the requested data
& the application is found acceptable &
complete.
Bioequivalence Review
• The 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.
• Applicants may request a waiver from performing in vivo
(testing done in humans) bioequivalence studies for
certain drug products where bioavailability may be
demonstrated by submitting data such as ;
1) A formulation comparison for products whose
bioavailability is self evident, for example, oral solutions,
injectables, or ophthalmic solutions where the formulations
are identical, or
2) Comparative dissolution.
• Alternatively, in-vivo bioequivalence testing
comparing the rate & extent of absorption of
the generic vs. the reference product is
required for most tablet & capsule dosage
forms. For certain products, a head to head
evaluation of comparative efficacy based
upon clinical endpoints may be required.
Chemistry/Microbiology Review
• The Chemistry/Microbiology review process
provides assurance that the generic drug will
be manufactured in a reproducible manner
under controlled conditions.
• Areas such as the applicant’s manufacturing
procedures, raw material specifications &
controls, sterilization process, container &
closure systems, accelerated & room
temperature stability data are reviewed to
assure that the drug will perform in an
acceptable manner.
Labeling Review
• The labeling review process ensures that the
proposed generic drug labeling (package insert,
container, package label & patient information) is
identical to that of the reference listed drug
• Except for differences due to changes in the
manufacturer, distributor, pending exclusively
issues, or other characteristics inherent to the
generic drug product (tablet size, shape or color,
etc.).
• Furthermore, the labeling review serves to
identify & resolve issues that may contribute to
medication errors such as similar sounding or
appearing drug names, & the legibility or
prominence of the name or strength.
Bioequivalence Review Acceptable
• If at the conclusion of the Bioequivalence
Review, it is determined that there are
deficiencies in the bioequivalence portion of
the application, a bioequivalence Deficiency
Letter is issued by the division of
Bioequivalence to the applicant.
• This deficiency letter details the deficiencies
& requests information & data to resolve
them.
Chemistry/Microbiology/Labeling
Review Acceptable
• If there are deficiencies involved in the
Chemistry/Manufacturing/Controls, Microbiology
or Labeling portions of the application, these
deficiencies are communicated to the applicant in a
facsimile.
• The facsimile instructs the applicant to provide
information & data to address the deficiencies &
provides regulatory direction on how to amend the
application.
• Once the above sections are found to be acceptable,
as well as, the pre-approval inspection &
bioequivalence portion of the application, then the
application moves toward approval.
Pre-approval Inspection Acceptable
• The pre-approval inspection determines
compliance with Current Good Manufacturing
Practices (cGMPs) as well as a product
specific evaluation concerning the
manufacturing process of the application
involved.
• If an unsatisfactory recommendation is
received, a not approvable letter may be
issued.
ANDAApproved
• After all components of the application are found to be
acceptable an approval or tentative approval letter is
issued to the applicant.
• If the approval occurs prior to the expiration of any
patents or exclusivities accorded to the reference listed
drug product, a tentative approval letter is issued to the
applicant which details the circumstances associated
with the tentative approval of the generic drug product
& delays approval until all patent/exclusivity issues
have expired.
• A tentative approval does not allow the applicant to
market the generic drug product.
References
• http://www.fda.gov/cder/guidance/index.htm
.
121725101005-S1.pptx

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121725101005-S1.pptx

  • 1. Presented By, K. Trideva Sastri M.Pharm 1 Semester (Pharmaceutics) Reg No. 121727101005 ABBREVIATED NEW DRUG APPLICATION (ANDA)
  • 2. • The Food and Drug Administration (FDA) is organized into eight centers, Introduction Sno. Name of the Center Abbreviation 1 The Center For Drug Evaluation And Research CDER 2 The Center For Biologics Evaluation And Research CBER 3 The Center For Devices And Radiological Health CDRH 4 The Center For Food Safety And Applied Nutrition CFSAN 5 The Center For Veterinary Medicine CVM 6 The National Center For Toxicological Research NCTR 7 The Office Of The Commissioner OC 8 The Office Of Regulatory Affairs ORA
  • 3. The CDER reviews the safety and Efficacy of drug products. The Center Director oversees 11 offices which include, • The Office of Pharmaceutical Science, • The Office of New Drugs, • The Office of Executive Programs, • The Office of Pharmacoepidemiology and Statistical Science, • The Office of Management, • The Office of Regulatory Policy, • The Office of Medical Policy, • The Office of Counter-Terrorism and Pediatric Drug Development, • The Office of Training and Communications, • The Office of Compliance, • The Office of Information Technology
  • 4. • Organizationally, the Office of Generic Drugs (OGD) is located within the CDER under the Office of Pharmaceutical Science. It consists of the following divisions: • Chemistry, • Bioequivalence, and • Labeling and Program Support
  • 5. • The Hatch-Waxman Act (HWA) to the Federal Food, Drug and Cosmetic Act (FD&C) gave clear statutory authority to submit Abbreviated New Drug Applications (ANDAs) for all approved innovator drugs. • With the passage of the HWA, who sought to market a generic version of a drug were not required to repeat the costly preclinical and clinical testing associated with a New Drug Application (NDA).
  • 6. • The OGD had its origins in the early 1970s and was known as the office of Drug Monographs. After the passage of the HWA in 1984, the office of Drug Monographs became the office of Drug Standards.
  • 7. • The Office of Drug Standards contained the Division of Generic Drugs (DGD) and the Division of Bioequivalence. • The OGD as we know it today was established in 1990 as part of the Office of Pharmaceutical Science (OPS). • Its mission is to ensure that safe and effective generic drugs are available for the American people. • The OGD ensures the safety and efficacy of generic drugs by employing a review process that is similar to the NDA process.
  • 8. • The primary difference between the Generic Drug Review process and the NDA review process is the study requirements.  For example, an ANDA generally requires a bio equivalence study between the generic product and the reference listed drug (RLD) product. • The safety and efficacy of the RLD product were established previously through animal studies, clinical studies and bioavailability studies. Thus, these studies need not be repeated for the ANDA.
  • 9. • Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) & clinical (human) data to establish safety & effectiveness.
  • 10. • A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics & intended use. • All approved products, both innovator & generic, are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. • Generic applicants must scientifically demonstrate that their product is bioequivalent (i.e. performs in the same manner as the innovator drug).
  • 11. • The rate of absorption or bioavailability of the generic drug, is compared 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 as that in the innovator drug.
  • 12. • Using bioequivalence as the basis for approving generic copies of the drug products was established by the “Drug Price Competition & Patent Term Restoration Act of 1984”, also known as the Waxman-Hatch Act. • Generic drug application reviewers focus on bioequivalence data, chemistry &microbiology data, request for plant inspection, & drug labeling information.
  • 13. Indispensability Ground 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.
  • 14. ANDA REQUIREMENT • Signed FDA form 356h. • Provides information regarding • The applicants name & address, name of the drug product, the product strength & route of administration, indication of drug master files cited, proposed indications, a statement regarding whether the product is for prescription or over the counter. • An index should specify volume & page number for each complete & detailed item.
  • 15. • 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. c) If a suitability petition is approved a reference to the FDA number that was assigned to that suitability petition.
  • 16. • Condition for use, including, a) A statement regarding the condition for which the drug will be used. b) A reference to the annoted labeling for the product & the currently approved labeling for the listed drug product. • A statement that active ingredient is the same as for that of the reference drug. For the combination product this must be shown for both active ingredient.
  • 17. • Route of administration, dosage form & strength. This should include a statement that the route of administration, dosage form & strength are same as the reference drug. • Bioequivalence. This should include information to demonstrate that the proposed drug is bioequivalent to the listed drug product.
  • 18. • 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. • Human Pharmacokinetics & Bioavailability. This include information concerning • The Design • The Dosing procedure • The number & frequency of blood & urine collection & Methodology for the assay.
  • 19. • 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.
  • 20. • 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.
  • 21. ANDA CERTIFICATION CLAUSES PARAG- RAPH I PARAG- RAPH II PARAG- RAPH III PARAG- RAPH IV When applicant submit ANDA to FDA, the applicant must Certify one of four things under section 505(j)(2)(A)(VII)
  • 22. PARA-I Required patent information has not been filed. FDA may approve generics immediately, one or more applicants may enter. PARA-II Patent has expired FDA may approve generics immediately, one or more applicants may enter. 22
  • 23. PARA-III Patent not expired, will be expired on a specific date. FDA may approved ANDA effective on the date of expiration, one or more applicant may enter. PARA-IV Patent is invalid or non infringed by generic applicant. Generic applicant file notice to patent holder. 23
  • 24. PARA IV CERTTIFICATION After 45 days Patent Holder doesn’t sue applicant ► FDA may approve ANDA. ANDA Applicant granted approval. After 45 days Patent Holder sues the Applicant ► 30months stay granted to Patent Holder. 30 Months stay expired For the first Applicant the EMR of 180 days starts with court’s decision. Subsequent approvals for EMRs are granted after expiry of first applicant’s 180 days. 30 Months stay not expired.
  • 25. DETAILS NDA ANDA IND 1.Chemistry,manufacturing, and controls yes Yes Yes 2.Nonclinical pharmacology and toxicology (Animal data) Yes No Yes 3. Human pharmacokinetics and bioavailability Yes Yes No 4. Microbiology Yes Yes No 5.Clinical data Yes Yes (BABE studies) No 6.Statistical Yes Yes Yes
  • 27. Applicant • An applicant means any person (usually a pharmaceutical firm) who submits an abbreviated new drug application, or an amendment or supplement to them, to obtain FDA approval to market a generic drug product.
  • 28. Acceptable & Complete? • An application must contain sufficient information to allow a review to be conducted in an efficient & timely manner. • Upon receipt of the application a pre-filling assessment of its completeness & acceptability is performed by a project manager within the regulatory support branch, Office of Generic Drugs. • If this initial review documents that the applicant contains all the necessary components, an “acknowledgment letter” is sent to the applicant.
  • 29. Refuse to file letter issued • If the application is missing one or more essential components, a “Refuse to File” letter is sent to the applicant. • No further review of the application occurs until the applicant provides the requested data & the application is found acceptable & complete.
  • 30. Bioequivalence Review • The 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. • Applicants may request a waiver from performing in vivo (testing done in humans) bioequivalence studies for certain drug products where bioavailability may be demonstrated by submitting data such as ; 1) A formulation comparison for products whose bioavailability is self evident, for example, oral solutions, injectables, or ophthalmic solutions where the formulations are identical, or 2) Comparative dissolution.
  • 31. • Alternatively, in-vivo bioequivalence testing comparing the rate & extent of absorption of the generic vs. the reference product is required for most tablet & capsule dosage forms. For certain products, a head to head evaluation of comparative efficacy based upon clinical endpoints may be required.
  • 32. Chemistry/Microbiology Review • The Chemistry/Microbiology review process provides assurance that the generic drug will be manufactured in a reproducible manner under controlled conditions. • Areas such as the applicant’s manufacturing procedures, raw material specifications & controls, sterilization process, container & closure systems, accelerated & room temperature stability data are reviewed to assure that the drug will perform in an acceptable manner.
  • 33. Labeling Review • The labeling review process ensures that the proposed generic drug labeling (package insert, container, package label & patient information) is identical to that of the reference listed drug • Except for differences due to changes in the manufacturer, distributor, pending exclusively issues, or other characteristics inherent to the generic drug product (tablet size, shape or color, etc.). • Furthermore, the labeling review serves to identify & resolve issues that may contribute to medication errors such as similar sounding or appearing drug names, & the legibility or prominence of the name or strength.
  • 34. Bioequivalence Review Acceptable • If at the conclusion of the Bioequivalence Review, it is determined that there are deficiencies in the bioequivalence portion of the application, a bioequivalence Deficiency Letter is issued by the division of Bioequivalence to the applicant. • This deficiency letter details the deficiencies & requests information & data to resolve them.
  • 35. Chemistry/Microbiology/Labeling Review Acceptable • If there are deficiencies involved in the Chemistry/Manufacturing/Controls, Microbiology or Labeling portions of the application, these deficiencies are communicated to the applicant in a facsimile. • The facsimile instructs the applicant to provide information & data to address the deficiencies & provides regulatory direction on how to amend the application. • Once the above sections are found to be acceptable, as well as, the pre-approval inspection & bioequivalence portion of the application, then the application moves toward approval.
  • 36. Pre-approval Inspection Acceptable • The pre-approval inspection determines compliance with Current Good Manufacturing Practices (cGMPs) as well as a product specific evaluation concerning the manufacturing process of the application involved. • If an unsatisfactory recommendation is received, a not approvable letter may be issued.
  • 37. ANDAApproved • After all components of the application are found to be acceptable an approval or tentative approval letter is issued to the applicant. • If the approval occurs prior to the expiration of any patents or exclusivities accorded to the reference listed drug product, a tentative approval letter is issued to the applicant which details the circumstances associated with the tentative approval of the generic drug product & delays approval until all patent/exclusivity issues have expired. • A tentative approval does not allow the applicant to market the generic drug product.
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