IPR NDA and ANDA

ANDA
by
Mahender.K
M.Pharm(pharmacology)
Under the guidance of
Dr. S.Y. Manjunath
Srikrupa institute of pharmaceutical sciences
Velkatta,kondapak,medak.
Andhra pradesh.

ABBREVIATED NEW DRUG APPLICATION (ANDA):
 It is a complete set of documents required to be
submitted as an application for getting approval for
a drug as a generic drug or generic version drug of
an already approved brand name drug to market
and sale generic version of that drug.
 Once approved, an applicant may manufacture and
market the generic drug product to provide a safe,
effective, low cost alternative to the public.

GOAL OF ANDA
 To reduce the price of the drug.
 To reduce the time development.
 Increase the bioavailability of the drug in
comparison to references list drug.

 The generic drug product are almost equally safe,
effective and comparable to that of an already available
brand name drug with respect to indications of use and
performance, route of administration, more importantly
their cost too is less compared to brand name drugs
 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).

BIOEQUILANCE
5
A generic drug is considered to be bioequivalent to the
brand name drug if:
 The rate and extent of absorption do not show a
significant difference from listed drug, or
 The extent of absorption does not show a significant
difference and any difference in rate is intentional or not
medically significant.

 Using bioequivalence as the basis for approving
generic copies of drug products was established by
the "Drug Price Competition and Patent Term
Restoration Act of 1984," also known as the
Waxman-Hatch Act.

 Abbreviated or Supplemental NDA:
o Abbreviated NDA: includes..
 Generic drug
 New combination of approved drugs
 Proportion of ingredients in combination is changed
o Supplemental NDA: includes..
 New intended use of the drug (labeling change)
 Dose, method or duration of administration is changed
 Change in manufacturing process or location

NDA VS. ANDA REVIEW PROCESS:
 Requirements for NDA:
 Labeling
 Pharmacology and
toxicology
 Chemistry
 Manufacturing
 Controls
 Microbiology
 Inspection
 Testing
 Animal studies
 Human studies
 Bioavailability
 Requirements for ANDA:
 Labeling
 Pharmacology and
toxicology
 Chemistry
 Manufacturing
 Controls
 Microbiology
 Inspection
 Testing
 Bioequivalence

 A pharmaceutical company can also submit ANDA for a
drug product electronically as electronic submission is
cost effective and takes less time as well.
 Once a generic drug or a drug innovated by a pharma
company as their brand name drug is approved by US
FDA it appears in the list of approved drugs which is also
called as ‘orange book’.

FORMAT OF ANDA:
 Three copies of application are required, an
archival copy, a review copy and a field copy.
 FDA will maintain guidance documents on the
format and content of applications to assist
applicants in their preparation.
 Application form
 Table of contents

FILING OF ANDA:
 Within 60 days after FDA receives an application, the
agency will determine whether the application may be
filed.
 The filing of an application means that FDA has made a
threshold determination that the application is sufficiently
complete to permit a substantive review.
 If FDA finds that none of the reasons for refusing to file
the application apply, the agency will file the application
and notify the applicant in writing.
 The date of filing will be the date 60 days after the date
FDA received the application. The date of filing begins
the 180-day period described in section 505(c) of the
act. This 180-day period is called the "filing clock."

 FDA will approve an application and issue the
applicant an approval letter on the basis of draft
labeling if the only deficiencies in the application
concern editorial or similar minor deficiencies in the
draft labeling.
 Such approval will be conditioned upon the
applicant incorporating the specified labeling
changes exactly as directed, and upon the
applicant submitting to FDA a copy of the final
printed labeling prior to marketing.
APPROVAL OF ANDA:

TIME FRAMES FOR REVIEWING ANDA BY FDA:
 Within 180 days of receipt of an application for a new
drug under section 505(b) of the act or an abbreviated
application for a new drug under section 505(j) of the
act, FDA will review it and send the applicant either an
approval letter under 314.105 or a complete response
letter under 314.110. This 180-day period is called the
"initial review cycle."
 At any time before approval, an applicant may withdraw
an application under 314.65 or an abbreviated
application under 314.99 and later submit it again for
consideration.
 The initial review cycle may be adjusted by mutual
agreement between FDA and an applicant or as
provided in 314.60 and 314.96, as the result of a major
amendment.

RESOURCES FOR ANDA SUBMISSIONS
 Guidance Documents for ANDAs
 Guidance documents represent the Agency's
current thinking on a particular subject. These
documents are prepared for FDA review staff and
applicants/sponsors to provide guidelines to the
processing, content, and evaluation/approval of
applications and also to the design, production,
manufacturing, and testing of regulated products.
 They also establish policies intended to achieve
consistency in the Agency's regulatory approach
and establish inspection and enforcement
procedures.

 Because guidences are not regulations or laws,
they are not enforceable, either through
administrative actions or through the courts. An
alternative approach may be used if such an
approach satisfies the requirements of the
applicable statute, regulations, or both.

LAWS, REGULATIONS, POLICIES AND
PROCEDURES
 The mission of FDA is to enforce laws enacted by the
U.S. Congress and regulations established by the
Agency to protect the consumer's health and safety.
 The Federal Food, Drug, and Cosmetic Act is the basic
food and drug law of the U.S. With numerous
amendments it is the most extensive law of its kind in
the world.
 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.

CODE OF FEDERAL REGULATIONS (CFR)
 The final regulations published in the Federal
Register (daily published record of proposed rules,
final rules, meeting notices, etc.) are collected in
the CFR.
 The CFR is divided into 50 titles which represent
broad areas subject to Federal regulations.
 The FDA's portion of the CFR interprets the
Federal Food, Drug and Cosmetic Act and related
statutes. Section 21 of the CFR contains most of
the regulations pertaining to food and drugs.

 MaPPs :
 CDER's Manual of Policies and Procedures
(MaPPs) provide official instructions for internal
practices and procedures followed by CDER staff to
help standardize the drug review process and other
activities, both internal and external.
 MaPPs define external activities as well. All
MAPPs are available for the public to review to get
a better understanding of office policies, definitions,
staff responsibilities and procedures.

 Amendments to an unapproved ANDA:
 An applicant may amend an abbreviated new drug application
that is submitted, but not yet approved, to revise existing
information or provide additional information.
 Amendments containing bioequivalence studies must contain
reports of all bioequivalence studies conducted by the
applicant on the same drug product formulation, unless the
information has previously been submitted to FDA in the
abbreviated new drug application.
 If a summary report of a bioequivalence study is submitted
and FDA determines that there may be bioequivalence issues
or concerns with the product, FDA may require that the
applicant submit a complete report of the bioequivalence study
to FDA.
 Submission of an amendment containing significant data or
information before the end of the initial review cycle
constitutes an agreement between FDA and the applicant to
extend the initial review cycle only for the time necessary to
review the significant data or information and for no more than
180 days.

NDA
ANDA
Applicable for new drug Applicable for generic drug
Take longer time ( 12-15
years)
Compare to NAD less time
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

REFERENCES:
 http://www.fda.gov/cder/guidance/index.htm.
 http://www.fda.gov/drugs/developmentapprovalprocess/
howdrugsaredevelopedandapproved/approvalapplicatio
ns/abbreviatednewdrugapplicationandagenerics/default.
htm
 http://www1.pointcross.com/source/ddg/charts/andachar
t.htm
 http://www.accessdata.fda.gov/scriptHYPERLINK
"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?fr=314.94"sHYPERLINK
"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?fr=314.94"/cdrh/cfdocs/cfcfr/CFRSearc
h.cfm?fr=314.94

IPR NDA and ANDA

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