ANDA Abbreviated New Drug Application

BY N.NARESH KUMAR m.pharm(cology)

Definition of ANDA:

AN “abbreviated new drug application” (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.

Definition of generic drug : A generic drug product is one that is comparable to an innovator drug product in dosage form. are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). quality.  All approved products. performance characteristics and intended use. route of administration. strength. both innovator and generic. .

e: a different salt or ester.000 products that held NDA”s under the 1938 act These products contain same active ingredients in the same amount and dosage form. often though they claim some unique characteristics i. the agency estimated that there were between 5-13 products without NDA”s that were identical and similar to each of the 13.  . a different dosage form or an extra added ingredients. different amount.  When the desi program was in progress.Advent of generic drug competition: DESI: drug efficacy study implementation.

Evolution of ANDA:  CHF patients who had been treated carefully with a specific dose of digoxin. went out of control upon getting prescriptions refilled revealed that digoxin. never subject to an NDA. but in the amount of drug released from the tablet into the body consequences could be life threatening  Investigations  The . varied from manufacturer to manufacturer not in quantity of actual drug per tablet .

 the agency responded with an order that each manufacturer submit an ANDA that included bioavailability studies showing the rate and extent of absorption into the body and bioequivalence studies permitted the individual generic products to be therapeutically equivalent to approved brand drug  The ANDA process .

office of of generic drugs. low cost alt to the American public . ANDA Generics:  An ANDA contains data which when submitted to FDA’s centre for drug evaluation and research . provides for the review and ultimate approval of a generic drug product  Once approved an applicant may mfg and market the generic drug product drug to provide a safe. efficant.

quality and performance characteristics applicants must scientifically demonstrate that their product is bioequivalance  Generic . A generic drug product is one that is Comparable to an innovator drug product in dosage form. route of administration. strength.

 One way to demonstrate bioequivalance is to measure the time it takes the generic drug to reach the blood stream in 24 to 36 hrs In a healthy volunteer gives the rate of absorption or bioavailability of generic drug which they can compare to the innovator drug  This .

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 bioequivalance is important and must .

packaged. Labeled and the name of the supplier of the active ingredient any person other than the applicant who performs a part of those operations  Identify  Identify . contained in a stated quantity of the drug the place where the drug is manufactured.Necessary items of ANDA  The composition of drug stating the name and amount of each ingredient whether active or not. processed.

labeling in conformity with the current GMP that the drug dosage form and components comply with specifications and tests described in an official compendium the drug differs from the compendium drug. packing. include certifications from the applicant and the methods used for mfg. quality and quantity  assure  if . processing. the specifications and tests applied to the drug and its components are adequate to assure their identity. strength.

 Outline the methods used in and the facility and control used for mfg. and packaging of the drug the drug require only an ANDA also specifies that there must be included adequate data to assure the bioavailability of the drug  If . processing.

goal of ANDA:  to  to reduce the price of the drug reduce the time development  increase the bioavailability of the drug in comparison to reference list drug .

HATCH ACT:  using the bioequivalance as the basis for approving generic copies of products was established by the “drug price commission and patent term restoration act of 1984”.WAXMAN.hatch act act expedites the availability of less costly generic drugs by permitting FDA to approve application to market generic versions of brand – names without conduct costly clinical trials  this . is known as Waxman .

 Also it provides mechanism to grant drug companies upto 5 years additional patent protection to compensate the patent life lost as a result of the time consumed during test required by FDA .

Conditions which must be fulfilled in order to ask an extension are :  Patent must not have expired at the time of filing the request for extension product must have been subjected to examination by  The FDA  The request for extension must have been filed within 60 days of the granting of FDA .

 the request for extension must have been filed at the latest during the last three months of the life of the patent of $750 is paid  A fee .

Inspection 8.Testing 9.Pharm/tox 3.Inspection 8.Labelling 2.Controls 6.Microbiology 7.bioavailability ANDA requirements 1.Animal studies 10.Pharm/tox 3.Chemistry 4.Manufacturing 5.Clinical studies 11.NDA vs ANDA review process: NDA requirements 1.Testing 9.Manufacturing 5.Chemistry 4.bioequivalence .Microbiology 7.Controls 6. Labelling 2.

Labelling: o Same information as brand name labelling May differ in excipients and product description (color. shapes) o .

Pharm/tox: o All inactive ingredients must be approved in either the reference list or similar NDA in same or higher levels .

Chemistry. manufacturing and controls: o o o o o o Components and composition Mfg and controls Batch formulation and records Description of facilities Packaging Stability .

Microbiology: o o Includes for anti infective drug compounds A complete description of the biochemical basis of drug action on microbial physiiology o Clinical microbiology laboratory methods Assure the sterility of products especially with injectibles o .

Inspection/testing : o Assure mfg facilities are in compliance with current GMP’S assure bioequivalance sites are in compliance with good clinical practices (cGCP’S) o .

Bioequivalance:  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 .



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