An application for a license to market a generic (or a duplicate) version of a drug that has already been granted an approval under a full NDA.

Transcription

1 ANDA REQUIREMENTS 1

2 Abbreviated New Drug Application (ANDA) An application for a license to market a generic (or a duplicate) version of a drug that has already been granted an approval under a full NDA. Generic drug applications are termed "abbreviated" because they are not required to provide clinical data to establish safety and efficacy, since these parameters have already been established. 2

3 According to the FDA, to substitute a generic for a brand name drug: It must contain the same active ingredients. It must have the same dosage strength (the amount of active ingredients, for example 20 mg). It must be the same dosage form (that is, it needs to be available in the same form as the original for example, as a liquid, pill, etc.). It must have the same route of administration It must deliver similar amounts of the drug to the bloodstream (that is, it needs to deliver a comparable amount of the drug into the bloodstream within a similar time period as the brand name drug). 3

4 Here s how generics and brand name drugs differ: They look different They could have different sizes, shapes, colours. They have different names. They might have different inactive ingredients. The generic costs less than the brand name drug. Generics can cost between 20 and 80 percent less. Different pharmacies carry different generics. Even the same pharmacy may change generic suppliers. 4

5 Requirements for ANDAs Must have an approved reference listed drug (RLD) and a patent certification Must be Therapeutic Equivalent to a reference product Meet the quality standards for chemistry and/or microbiology All related facilities have acceptable cgmp compliance 5

6 THERAPEUTIC EQUIVALENCE Pharmaceutically Equivalent (PE) Same active ingredient(s) Same dosage form Same route of administration Identical in strength or concentration May differ in characteristics such as shape, excipients, packaging... Bioequivalent (BE) The property in which two drugs with identical active ingredients have similar bioavailability and produce same effect at the site of action. 6

7 Use of bioequivalence as the base for approving generic drug products was established by the "Drug Price Competition and Patent Term Restoration Act of 1984" also known as the Hatch - Waxman Act. 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 up to 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. 7

8 ANDA requirement 1) Signed form 2) Index 3) Information on the basis of which ANDA submitted A) Name of reference drug B) Dosage form C) Strength D) Concentration use 4) Statement that the active ingredient is same as that of the reference drug 8

9 5) Route of administration 6) Bioequivalence 7) Label 8) Chemistry, manufacture, control 9) Sample 10) Analytical method 9

10 NDA and ANDA Requirements Brand Name Drug NDA Requirements Generic Drug ANDA Requirements 1. Chemistry 1. Chemistry 2. Manufacturing 2. Manufacturing 3. Controls 3. Controls 4. Labeling 4. Labeling 5. Testing 5. Testing 6. Animal Studies 7. Clinical Studies 6. Bioequivalence 8. Bioavailability 10

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13 References Richard A. Gaurino, in New drug approval process, 2nd edition, marcel decckar Inc 270, Newyork. Remington The Science and Practice of Pharmacy,21 th Edition, volume- 2, Kuchekar B. S., in Pharmaceutical jurisprudence, 10 th Edition, june 2003,Nirali Prakashan. Leon lachman, Hebart A. liberman, In The Theory and Practice of Industrial Pharmacy,3rd edition,varghese Publication House Bombay. 13

14 htpp://en.wikipedia.org/newdrugapplication

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