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ANIRBAN SAHAAMITY INSTITUTE OF PHARMACY

M.Pharm (Pharmaceutics)

Semester-1

Enrollment No: A10647014005

Abbreviated New Drug Application (ANDA) It is an applicationfor generic versions of Off-Patent Drugs to receive FDAapproval 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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Safety and effectiveness of the drug in its proposed use

The methods used in manufacturing the drug and thecontrols used to maintain the drug's quality are adequate topreserve 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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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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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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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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Commonly known as “Drug Price Competition & Patent TermRestoration Act” of 1984.

“The Hatch-Waxman Act” is an act dealing with the approval ofgeneric drugs and associated conditions for getting theirapproval from FDA, patent term extension and Orange BookListing.”

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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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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NDA VS ANDA

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Guidance documents to help prepare ANDAs are listed togetherin 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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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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Amoxil (NDA APPLICANT DR.REDDY’S) GENERIC DRUGMANUFACTURER AUROBINDO PHARMA APPROVED ON NOV 9TH ,2005

Ultracet (NDA APPLICANT JANSSEN PHARMS) GENERIC DRUGMANUFACTURER MYLAN LABS APPROVED ON SEPTEMBER 26TH ,2008.

ACCUPRIL(NDA APPLICANT PFIZER) GENERIC DRUG MANUFACTURERAUROBINDO PHARMA Approved ON APRIL 29th ,2013.

EXELON(NDA APPLICANT NOVARTIS)GENERIC DRUG MANUFACTURERDR.REDDY’S APPROVED ON OCTOBER 31,2007.

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http://www.fda.gov

www.fda.gov/AboutFDA/CentersOffices/.../CDER

http://www.fda.gov/OGD

Generic Drug Product Development Solid Oral Dosage Forms By Leon Shargel & IsadoreKanfer

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