1. Development and Review Process of NDA, ANDA/AADA and OTC Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Associate Professor Department of Pharmaceutics KLE University BELGAUM – 590 010

2. 28/07/2008Dept. of Pharmaceutics2 New Drug Development Process

3. 28/07/2008Dept. of Pharmaceutics3 Fundamentals of NDA Submissions 1.Index 2.Summary 3.Chemistry, Manufacturing and Control 4.Samples, Methods Validation Package and Labeling 5.Nonclinical Pharmacology and Toxicology

4. 28/07/2008Dept. of Pharmaceutics4 Fundamentals of NDA Submissions 6. Human Pharmacokinetics and Bioavailability 7. Microbiology ( for anti-microbial drugs only) 8. Clinical Data 9. Safety Update report ( typically submitted 120 days after the NDA’s submission )

5. 28/07/2008Dept. of Pharmaceutics5 Fundamentals of NDA Submissions 10. Statistical 11. Case Report Tabulations 12. Case Report Forms 13. Patent Information 14. Patent Certification

6. 28/07/2008Dept. of Pharmaceutics6 New Drug Application (NDA) Classifications 1.New molecular entity 2.New salt of previously approved drug (not a new molecular entity) 3.New formulation of previously approved drug (not a new salt OR a new molecular entity) 4.New combination of two or more drugs

7. 28/07/2008Dept. of Pharmaceutics7 New Drug Application (NDA) Classifications 5. Already Marketed Drug Product – Duplication (i.e., new manufacturer) 6. New Indication (claim) for Already Marketed Drug ( includes switch in marketing status from prescription to OTC) 7. Already Marketed Drug Product – No previously Approved NDA

8. 28/07/2008Dept. of Pharmaceutics8 NDA Review Process

9. 28/07/2008Dept. of Pharmaceutics9 ANDA/AADA (Abbreviated New Drug Application) A generic drug product is one that is comparable to an innovator drug product ( also known as the reference listed drug (RLD) product as identified in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristics and intended use. A generic drug product is one that is comparable to an innovator drug product ( also known as the reference listed drug (RLD) product as identified in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristics and intended use.

10. 28/07/2008Dept. of Pharmaceutics10 ANDA/AADA (Abbreviated New Drug Application) “ANDA” is the abbreviation for Abbreviated New Drug Application. “ANDA” is the abbreviation for Abbreviated New Drug Application. It contains data which when submitted to FDA’s CDER, office of generic drugs, provides for the review and ultimate approval of a generic drug product. It contains data which when submitted to FDA’s CDER, office of generic drugs, provides for the review and ultimate approval of a generic drug product. Once approved an applicant may manufacture and market the generic drug product provided all issues related to patent protection and exclusivity associated with RLD have been resolved. Once approved an applicant may manufacture and market the generic drug product provided all issues related to patent protection and exclusivity associated with RLD have been resolved.

11. 28/07/2008Dept. of Pharmaceutics11 ANDA/AADA (Abbreviated New Drug Application) Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. These parameters were established upon the approval of the innovator drug product, which is the first version of the drug product approved by the FDA. These parameters were established upon the approval of the innovator drug product, which is the first version of the drug product approved by the FDA.

12. 28/07/2008Dept. of Pharmaceutics12 ANDA/AADA Review Process

13. 28/07/2008Dept. of Pharmaceutics13 OTC (Over-the-Counter Drug Products)  Over-the Counter (OTC) drug products are those drugs that are available to consumers without a prescription.  There are more than 80 classes (therapeutics categories) of OTC drugs, ranging from acne drug products to weight control drug products.  There are more than 100, 000 OTC drug products marketed, encompassing about 800 significant active ingredients.

14. 28/07/2008Dept. of Pharmaceutics14 OTC (Over-the-Counter Drug Products)  OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations and labeling.  Monographs will continually be updated adding additional ingredients and labeling as needed.  The newer OTC products [previously available only by prescription] are first approved through the NDA system and their “switch” to OTC status is approved via the NDA system.

15. 28/07/2008Dept. of Pharmaceutics15 OTC Drug Monograph Review Process

16. 28/07/2008Dept. of Pharmaceutics16 E-mail: bknanjwade@yahoo.co.inbknanjwade@yahoo.co.in Cell No: 09448716277