NDA and ANDA regulatory approval process

Pharmaceutical drug approval process regarding NDA and ANDA.

1. DELIEVERED BY MISS. JAGRUTI K. KALE (F.Y. M.PHARM) ROLL NO : 8 Sir .Dr. M. S. Gosavi College Of Pharmaceutical Education And Research . 1 NDA AND ANDA REGULATORY APPROVAL PROCESS

2. 1. NEW DRUG APPLICATION (NDA) Introduction Objective NDA format Requirements for NDA NDA content NDA review Action letter 2 CONTENTS

3. 2. ABBREVIATED NEW DRUG APPLICATION (ANDA) Introduction Goal of ANDA Requirements for filling ANDA Steps of ANDA Types of ANDA Patent certification condition 3

4. An application submitted by the manufacturer of a drug to the FDA- after clinical trials have been completed- for a license to market the drug for a specified. New Drug Application is a regulatory mechanism that is designed to give FDA sufficient information to make a meaningful evaluation of a new drug. 4 WHAT IS NDA ?

5. Whether the drug`s proposed labeling (package Insert) is appropriate, and what it should contain. Whether the drug is safe and effective in its proper use, and whether the benefits of the drug outweigh the risks. Whether the methods used in the 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. 5 OBJECTIVE OF NDA

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8. No. of copies – before 1965- 3 copies & now only 2 copies. Archival copy- It contains all sections of the NDA including cover latter, form FDA-356 h (application to market a new drug for human use) administrative section, NDA index and all technical sections. It is the only copy that contains the case report tabulation and case report form. Review copy – It contains a NDA technical section along with the cover letter, form FDA-356, NDA index as well as individual table of content, the labeling section and application summary. 8 REQUIREMENT FOR NDA

9. Field copy – This is required by FDA inspector during pre-approval facilities inspections. In the addition to the content review copy it includes the CMC (Chemistry, manufacturing and the control) and method validation package. 9

10. 10 Assembling the application Folder -color folder Eg. Archival red -Name of applicant and name of drug product -NDA no. if known copy- blue chemistry section- Paper size and binding -page 8.5 – 11 inches Bound at left side -Use both side -Accurately no.

11. Pagination -Page no both copy should have same. Volume size and identification -Not more than 2 inches thick -Should have name of applicant, drug NDA no. Packing carton - Box size 14-12-9.5 inches 11

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16. Usually six different teams responsible for reviewing NDA includes : 1)Chemistry 2)Clinical 3)Pharmacology/Toxicology 4)Statistics 5)Biopharmaceutical 6)Microbiology 16 NDA REVIEW

17. 17 ACTION LETTERS

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19. Abbreviated New Drug Application (ANDA) is 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(i.e. the drug has already met the statutory standards for safety & effectiveness). ANDA are used when a patent has expired for a product that has been on the U.S. market & a company wishes to market a copy. It contains data which submitted to FDA`s CDER, office of generic drugs; provides for the review & ultimate approval of generic drugs. 19 WHAT IS ANDA ?

20. 20 GOAL OF ANDA

21. The required patent information has not been filed. The patent has expired. Not expired but will expire on particular date. by the drug for which ANDA applicant require approval. If more than one ANDA for particular drug: First filed ANDA is entitled to have 180 days marketing exclusivity period followed by approval against later filled ANDA. Patent is unenforceable or invalid or not be infringed 21 REQUIREMENTS FOR FILLING ANDA

22. 22 STEPS FOR FILLING ANDA

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26. 26 TYPES OF ANDA FILLING

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28. As a result of Hatch-Waxman, the Food Drug and Cosmetics Act requires that, among other things, one of the following four certifications be made when filing an ANDA: The drug has not been patented. The patent has already expired. The generic drug will not go on the market until the patent expiration date passes. The patent is not infringed or is invalid. These certifications are referred to as the paragraphs I, II, III, and IV certifications. 28 Paragraph IV Certification

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30. 30 PATENT RESTORATION

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32. To begin the FDA approval process, a generic applicant must do two things: (a) certify in its ANDA that the patent in question is invalid or is not infringed by the generic product (the “ paragraph IV certification”) and (b) notify the patent holder of the submission of the ANDA. If the patent holder files an infringement suit against the generic applicant within 45 days of the ANDA notification, FDA approval to market the generic version is automatically postponed for 30 months (unless, before that time, the patent expires or is judged to be invalid or not infringed). 32 ANDA and the 30-Month Stay Period

33. An applicant can seek FDA approval to market a generic drug before the expiration of the patent of the branded product upon which the generic is based. The first company to submit a paragraph IV certification ANDA to the FDA has the exclusive right to market the generic drug for 180 days. This 180-day exclusivity period was included in the legislation to encourage generic companies to invest in the required product testing and to cover expensive legal challenges to pioneer (innovator) products. Thus the generic industry becomes competitive. 33 The 180-Day Exclusivity Period

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35. Book reference Pisano, D.J. and Mantu , D.S., A Guide For Prescription DRUGs, Medical Devices, AND Biologics. Share, L. and Kinder, I. eds., 2013.  Generic drug product development : solid oral dosage forms . CRC Press. www.fda/cder.gov 35 REFERENCE

36. Article references Mossinghoff, G.J., 1999. Overview of the Hatch-Waxman Act and its impact on the drug development process.  Food & Drug LJ ,  54 , p.187. Mehl, A.B., 2006. The Hatch-Waxman Act and market exclusivity for generic manufacturers: an entitlement or an incentive.  Chi.-Kent L. Rev. ,  81 , p.649. 36

37. Mehl , A.B., 2006. The Hatch-Waxman Act and market exclusivity for generic manufacturers: an entitlement or an incentive.  Chi.-Kent L. Rev. ,  81 , p.649. Submissions—Content, A.N.D.A., 2014. Guidance for Industry.  Center for Biologics Evaluation and Research (CBER) . http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.html Mossinghoff , G.J., 1999. Overview of the Hatc Mantus , D. and Pisano, D.J. eds., 2014.  FDA Regulatory Affairs . CRC Press. h-Waxman Act and its impact on the drug development process.  Food & Drug LJ ,  54 , p.187. 37 REFERENCES