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 590 010,28/07/2008,Dept. of Pharmaceutics,2,New Drug Development Process,28/07/2008,Dept. of Pharmaceutics,3,Fundamentals of NDA
2、Submissions,IndexSummaryChemistry, Manufacturing and ControlSamples, Methods Validation Package and LabelingNonclinical Pharmacology and Toxicology,28/07/2008,Dept. of Pharmaceutics,4,Fundamentals of NDA Submissions,6. Human Pharmacokinetics and Bioavailability7. Microbiology ( for anti-microbial dr
3、ugs only)8. Clinical Data9. Safety Update report ( typically submitted 120 days after the NDAs submission ),28/07/2008,Dept. of Pharmaceutics,5,Fundamentals of NDA Submissions,10. Statistical11. Case Report Tabulations12. Case Report Forms13. Patent Information14. Patent Certification,28/07/2008,Dep
4、t. of Pharmaceutics,6,New Drug Application (NDA) Classifications,New molecular entity New salt of previously approved drug (not a new molecular entity)New formulation of previously approved drug (not a new salt OR a new molecular entity) New combination of two or more drugs,28/07/2008,Dept. of Pharm
5、aceutics,7,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,28
6、/07/2008,Dept. of Pharmaceutics,8,NDA Review Process,28/07/2008,Dept. of Pharmaceutics,9,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 FDAs list o
7、f Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristics and intended use.,28/07/2008,Dept. of Pharmaceutics,10,ANDA/AADA (Abbreviated New Drug Application),“ANDA” is the abbreviation for Abbreviated Ne
8、w Drug Application.It contains data which when submitted to FDAs 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
9、exclusivity associated with RLD have been resolved.,28/07/2008,Dept. of Pharmaceutics,11,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 safe
10、ty 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.,28/07/2008,Dept. of Pharmaceutics,12,ANDA/AADA Review Process,28/07/2008,Dept. of Pharmaceutics,13,OTC (Over-the-Counter Drug Pr
11、oducts),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 ma
12、rketed, encompassing about 800 significant active ingredients.,28/07/2008,Dept. of Pharmaceutics,14,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 add
13、itional 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.,28/07/2008,Dept. of Pharmaceutics,15,OTC Drug Monograph Review Process,28/07/2008,Dept. of Pharmaceutics,16,THANK YOU,E-mail: bknanjwadeyahoo.co.in Cell No: 09448716277,
