A View For Upcoming Drug Discovery

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ANIRBAN SAHA
AMITY INSTITUTE OF PHARMACY
M.Pharm (Pharmaceutics)
Semester-1
Enrollment No: A10647014005

2.  Abbreviated New Drug Application (ANDA) It is an application
for generic versions of Off-Patent Drugs to receive FDA
approval with less cost or no preclinical and clinical testing.
 A generic drug product is one that is comparable to an
innovator drug product in dosage form, strength, route
of administration, quality, performance characteristics and
intended use. All approved products, both innovator and
generic, are listed in FDA's Approved Drug Products with
Therapeutic Equivalence Evaluations (Orange Book).
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3.  Safety and effectiveness of the drug in its proposed use
 The methods used in manufacturing the drug and the
controls used to maintain the drug's quality are adequate to
preserve the drug's identity, strength, quality, and purity .
 To reduce the price of the drug.
 To reduce the time for development.
 Drug's proposed labeling is appropriate.
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4. Why it is Abbreviated?
•The term Abbreviated is used in generic drug applications
because these applications does not require preclinical and
clinical data to establish safety and efficacy.
•Scientific demonstration of the bioequivalence is important
and must.
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5. Necessary Items of ANDA
•The composition of drug stating the name and
amount of each ingredient whether active or not,
contained in a stated quantity of the drug.
•Identify the place where the drug is manufactured,
processed, packaged, labeled and the name of the
supplier of the active ingredient.
•Identify any person other than the applicant who
performs a part of those operations.
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6.  In 1970 FDA established the ANDA as a mechanism for the
review and approval of generic versions.
 During 1970-1983, generic product applicants were required to
submit complete safety and efficacy through clinical trials.
 Neither of these approaches was considered satisfactory and so
originated Hatch Waxman Act on 1984.
Orrin Grant Hatch Henry Arnold Waxman
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7.  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, patent term extension and Orange Book
Listing.”
 It is because of this Act that there is the availability of less costly
generic drugs into the market without conducting costly and
duplicative clinical trials.
 At the same time, the brand-name companies (innovators) can
apply for upto five additional years longer patent protection for
the new medicines that they developed to make up the time lost
while their products were going through FDA's approval process.
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8.  Same active ingredients.
 Same route of administration.
 Same dosage form.
 Same strength.
 Same conditions of use other active and inactive ingredients
already approved in a similar NDA.
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9. NDA VS ANDA
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11. Guidance documents to help prepare ANDAs are listed together
in the following categories:
 Biopharmaceutics:
Bioavailability and Bioequivalence Studies for Orally
Administered Drug Products - General Considerations .This
guidance should be useful for applicants planning to conduct
bioavailability (BA) and bioequivalence (BE) studies intended
for submission in an ANDA .
 Drug Master Files:
A Drug Master File (DMF) is a submission to the FDA that may
be used to provide confidential detailed information about
facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more human
drugs.
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12.  Application form
 Table of contents
 Reference and test drugs
 Conditions of use
 Active ingredients
 Route of administration, dosage form and strength.
 Bioequivalence review
 Labeling
 Data regarding Samples: need not be submitted until
requested by FDA.
 Patent certification
 Financial certification or disclosure statement.
 Chemistry, manufacturing and controls
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14.  Amoxil (NDA APPLICANT DR.REDDY’S) GENERIC DRUG
MANUFACTURER AUROBINDO PHARMA APPROVED ON NOV 9TH ,2005
 Ultracet (NDA APPLICANT JANSSEN PHARMS) GENERIC DRUG
MANUFACTURER MYLAN LABS APPROVED ON SEPTEMBER 26TH ,2008.
 ACCUPRIL(NDA APPLICANT PFIZER) GENERIC DRUG MANUFACTURER
AUROBINDO PHARMA Approved ON APRIL 29th ,2013.
 EXELON(NDA APPLICANT NOVARTIS)GENERIC DRUG MANUFACTURER
DR.REDDY’S APPROVED ON OCTOBER 31,2007.
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15.  http://www.fda.gov
 www.fda.gov/AboutFDA/CentersOffices/.../C
DER
 http://www.fda.gov/OGD
 Generic Drug Product Development Solid Oral
Dosage Forms By Leon Shargel & Isadore
Kanfer
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