ANDA

It is applicable for the Generic drugs

1. ABBREVIATED NEW DRUG APPLICATION [ANDA] Mr. Sagar Kishor savale [Department of Pharmaceutics)] [email protected] 2015-2016 1

2. CONTENTS Introduction. History. Content of ANDA. Requirements of ANDA. Supplemental New drug application (SNDA) Difference between ANDA & NDA. References. 2

3. INTRODUCTION An abbreviated new drug application (ANDA) is specifically designed for an approval of generic drug product * . * Application for products similar to “already approved drugs" in terms of same dosage form, same route of administration, active ingredients and other conditions Such applications were required to show bioequivalence if FDA thought the products have potential bioavailability problem. 3

4. GENERIC DRUG …… To nominate a generic drug, it must be a drug product that is comparable to an innovator drug product in:- Dosage form. Strength. Route of administration. Quality. Performance characteristics. Intended use. 4

5. It termed "abbreviated" because they generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. 5

6. 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. 6

7. HISTORY The Waxman-Hatch Act also known as the “Drug Price Competition and Patent term restoration Act of 1984”. It established bioequivalence as the basis for approving generic copies of drug products. This Act permits FDA to approve ANDAs submitted to market generic version of brand name drugs without conducting costly and duplicative preclinical and clinical trials to establish safety and efficacy . 7

8. REFERENCE LISTED DRUGS: A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA. 8

9. INFORMATION REQUIRED FOR FILLING ANDA . Product’s formulation Manufacturer’s procedure Control procedure Testing Facilities Dissolution profile Labeling 9

10. Additional information In vivo bioavailability of the prepared generic drug product comparing it to the brand name drug product. Criteria for bio-equivalence was known as 75/75 rule. It means that 75% of the subjects required to have concentration in the plasma between 75% - 125% when compared with the branded product 10

11. CONTENT OF ANDA GENERAL: It includes Bio-availability & bioequivalence studies. ( BABE) “ Bioequivalence measures the time it takes for generic drug to reach blood stream as compared to reference drug in healthy volunteers.” 11

12. LEGAL REQUIREMENTS & GUIDANCE DOCUMENTS: Guidance documents are prepared for FDA review staff and applicants to provide guidelines for processing, content, evaluation, and approval of application. An ANDA may follow the same items as referred to in NDA except Clinical data section. Information on Submission of ANDA in eCTD format can be found at http://www.fda.gov/cder/regulatory/ersr/ectd.htm http://www.fda.gov/cder/regulatory/ersr/ectd/5640-v1.2.pdf http://www.fda.gov/cder/ogd 12

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14. Not a part of CTD CTD Not a part of CTD CTD 14

15. CTD MODULES ANDA REQUIREMENT Module 2 Common Technical Document Summaries yes Module 3 Quality yes Module 4 Nonclinical Study Reports (Animal studies) no Module 5 Clinical Study Reports (BA/BE studies) yes 15

16. MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES DRUG SUBSTANCE (NAME, MANUFACTURER) 2.3.S.1 General Information (name, manufacturer) 2.3.S.2 Manufacture (name, manufacturer) 2.3.S.3 Characterisation (name, manufacturer) 2.3.S.4 Control of Drug Substance (name, manufacturer) 2.3.S.5 Reference Standards or Materials (name, manufacturer) 2.3.S.6 Container Closure System (name, manufacturer) 2.3.S.7 Stability (name, manufacturer) 16

17. MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES DRUG PRODUCT (NAME, DOSAGE FORM) 2.3.P.1 Description and Composition of the Drug Product (name, dosage form) 2.3.P.2 Pharmaceutical Development (name, dosage form) 2.3.P.3 Manufacture (name, dosage form) 2.3.P.4 Control of Excipients (name, dosage form) 2.3.P.5 Control of Drug Product (name, dosage form) 2.3.P.6 Reference Standards or Materials (name, dosage form) 2.3.P.7 Container Closure System (name, dosage form) 2.3.P.8 Stability (name, dosage form) 17

18. ANDA Review process 18

19. DETAILS NDA ANDA IND 1.Chemistry,manufacturing, and controls yes Yes Yes 2.Nonclinical pharmacology and toxicology (Animal data) Yes No Yes 3. Human pharmacokinetics and bioavailability Yes Yes No 4. Microbiology Yes Yes No 5.Clinical data Yes Yes (BABE studies) No 6.Statistical Yes Yes Yes 19

20. Ammendments to an unapproved ANDA An applicant of an ANDA can ammend an ANDA that is not yet approved. The time awarded is not more than 180 days. Postmarketing Reports Each applicant having an approved ANDA shall comply with the requirements regarding the reporting and record keeping of adverse drug reaction in te same way as those holding NDA 20

21. SUPPLEMENTAL NEW DRUG APPLICATIONS A SNDA is submitted to FDA for any changes to an approved NDA or an ANDA. It is appllied if any change occurs in area of Chemistry & manufacturing of drug and its direction for use. Approval of SNDA is required before certain changes may be implemented. 21

22. Therapeutic Equivalence Evaluations Codes A  Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which : (1) there are no known or suspected bioequivalence problems.  These are designated AA , AN , AO , AP , or AT , depending on the dosage form; or (2) actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence.  These are designated AB . 22

23. B  Drug products that FDA at this time, considers NOT to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence.   Often the problem is with specific dosage forms rather than with the active ingredients.  These are designated BC , BD , BE , BN , BP , BR , BS , BT , BX, or B* . 23

24. Patent Certification(s) Reference Listed Drug based upon a suitability petition.  An abbreviated new drug application that refers to a Reference Listed Drug (RLD) approved pursuant to a suitability petition must demonstrate that the proposed product is bioequivalent to the RLD, and it must include appropriate patent certification(s) and an exclusivity statement with respect to the listed drug which served as the basis for the approved suitability petition. 24

25. SUMMARY ANDA are specifically designed to facilitate the manufacturers of generic drug products to rapidly provide these products to consumer at a cheaper rate. 25