Development And Review Process Of NDA, ANDA/AADA and OTC


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Development And Review Process Of NDA, ANDA/AADA and OTC

  1. 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. 2. New Drug Development Process
  3. 3. Fundamentals of NDA Submissions <ul><li>Index </li></ul><ul><li>Summary </li></ul><ul><li>Chemistry, Manufacturing and Control </li></ul><ul><li>Samples, Methods Validation Package and Labeling </li></ul><ul><li>Nonclinical Pharmacology and Toxicology </li></ul>
  4. 4. Fundamentals of NDA Submissions <ul><li>6. Human Pharmacokinetics and Bioavailability </li></ul><ul><li>7. Microbiology ( for anti-microbial drugs only) </li></ul><ul><li>8. Clinical Data </li></ul><ul><li>9. Safety Update report ( typically submitted 120 days after the NDA’s submission ) </li></ul>
  5. 5. Fundamentals of NDA Submissions <ul><li>10. Statistical </li></ul><ul><li>11. Case Report Tabulations </li></ul><ul><li>12. Case Report Forms </li></ul><ul><li>13. Patent Information </li></ul><ul><li>14. Patent Certification </li></ul>
  6. 6. New Drug Application (NDA) Classifications <ul><li>New molecular entity </li></ul><ul><li>New salt of previously approved drug (not a new molecular entity) </li></ul><ul><li>New formulation of previously approved drug (not a new salt OR a new molecular entity) </li></ul><ul><li>New combination of two or more drugs </li></ul>
  7. 7. New Drug Application (NDA) Classifications <ul><li>5. Already Marketed Drug Product – Duplication (i.e., new manufacturer) </li></ul><ul><li>6. New Indication (claim) for Already Marketed Drug ( includes switch in marketing status from prescription to OTC) </li></ul><ul><li>7. Already Marketed Drug Product – No previously Approved NDA </li></ul>
  8. 8. NDA Review Process
  9. 9. ANDA/AADA (Abbreviated New Drug Application) <ul><li>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. </li></ul>
  10. 10. ANDA/AADA (Abbreviated New Drug Application) <ul><li>“ ANDA” is the abbreviation for Abbreviated New Drug Application. </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>
  11. 11. ANDA/AADA (Abbreviated New Drug Application) <ul><li>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. </li></ul><ul><li>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. </li></ul>
  12. 12. ANDA/AADA Review Process
  13. 13. OTC (Over-the-Counter Drug Products) <ul><li>Over-the Counter (OTC) drug products are those drugs that are available to consumers without a prescription. </li></ul><ul><li>There are more than 80 classes (therapeutics categories) of OTC drugs, ranging from acne drug products to weight control drug products. </li></ul><ul><li>There are more than 100, 000 OTC drug products marketed, encompassing about 800 significant active ingredients. </li></ul>
  14. 14. OTC (Over-the-Counter Drug Products) <ul><li>OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations and labeling. </li></ul><ul><li>Monographs will continually be updated adding additional ingredients and labeling as needed. </li></ul><ul><li>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. </li></ul>
  15. 15. OTC Drug Monograph Review Process
  16. 16. THANK YOU E-mail: [email_address] Cell No: 09448716277