Anda for generic drugs in Regulatory affairs

abbreviated new drug application for generic drug product in regulatory affairs,M.pharmacy

1. ANDA FOR GENERIC DRUGS Guided By, Presented By, Dr. M. Shende Sir Miss.Prerana Husukale Roll No- 03 M.pharm-I [Pharmaceutics] Government College Of Pharmacy,karad

2. INTRODUCTION HISTORY & BASIC CONTENT OBJECTIVE OF ANDA DIFFERENCE BETWEEN NDA & ANDA DIFFERENCE BETWEEN INNOVATOR & GENERIC DRUG GENERIC DRUG APPROVAL BROAD OUTLINE OF ANDA INFORMATION REQUIRED FOR FILLING ANDA PATENT CERTIFICATION ORAGE BOOK REFERENCE AGENDA

3. US-FDA: The United States Food and Drug Administration is an regulatory agency within the U.S established for Public Health and Service. Headquarter: White Oak, Maryland PARTS OF US FDA : Center for Drug Evaluation and Research (CDER) Code of Federal Regulation(CFR) Investigational New Drug Application(INDA) New Drug Application(NDA) Abbreviated New Drug Application(ANDA INTRODUCTION

4. In 1938, proof of safety In 1962, ‘THE KEFAUVER HARIS AMENDMENTS’ led to ‘DRUG EFFICACY STUDY IMPLEMENTATION [DESI]. FDA’s realization Mid 1966 notice in Federal Register DESI review ultimately led to evolution of ANDA concept HISTORY

5. A written request to the U.S. Food & Drug Administration(FDA’s CDER)office of generic drug, to manufacture and market a generic drug in United States. Abbreviated New Drug Application are ‘Already Abbreviated’ since they do not require to conduct clinical trials & require less information than a NDA. All approved products, both Innovator & generic drug will listed in the Orange Book. ABBREVIATED NEW DRUG APPLICATION [ANDA]

6. OBJECTIVE OF ANDA

7. DIFFERENCE BETWEEN NDA & ANDA

8. DIFFERENCE BETWEEN INNOVATOR & GENERIC

9. The generic drug is a safe, effective& economical substitute of a brand name drug product. According to the FDA, generic drugs are identical or within an acceptable bioequivalent range to the brand- name counterpart with respect to pharmacokinetics and pharmacodynamics properties. This drug products must be bioequivalent with Reference drug in terms of Active Pharmaceutical Ingredients(API) Route of administration Dosage form Strength & indication Safety GENERIC DRUG

10. WHEN GENERIC DRUG MARKETED After patent and exclusivity protection ends Patent owner waives its rights FDA requirements are met Basic G eneric D rug R equirements Are – Same active ingredient Same route of administration Same dosage form Same strength Same condition of use Inactive ingredients already approved in similar NDA

11. The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs and brand-name companies gained restoration of patent life of their products lost during the FDA’s approval process. FDA Legislative Support For Generic Drugs

12. G ENERIC DRUG APPROVAL

13. Product’s formulation Manufacturer’s procedure Control procedure Testing Facilities Dissolution profile Labelling INFORMATION REQUIRED TO FILLING ANDA

14. Para I certification : There is no patent for the drug listed in the orange book. Para II certification : Patent is listed but expired. Para III certification: Patent is listed, Is valid but the generic wants approval to market the drug once the pertiment patent expires. Para IV certification: Is the most critical of all & gives to almost all the anti- competitive practices associated with the Waxman amendment act. PATENT CERTIFICATION

15. The publication Approved Drug Product’s With Therapeutic Equivalence Evaluations. Identifies drug products approved on the basis of safety & effectiveness by FDA under the Federal Food, Drug & Cosmetic Act & related patent and exclusivity information. 4 parts : Approved prescription drug products with therapeutic equivalence Approved OTC drug products for those drugs may not be marked without NDA or ANDAs [ not covered in OTC monograph] Drug products with approval under section 505 of the FD&C Act Administered by the Center For Biologics Evaluation & Research. A cumulative list of approved products that have never been marketed, are for exportation , are for military use. ORANGE BOOK

16. www.generic drug approval. Wikipedia www.FDA.gov.in Theory and Practice of Industrial Pharmacy by Lachmann and Libermann. REFERENCE