development and review process of nda, anda/aada and otc

Development and Review Process of Development and Review Process of NDA, ANDA/AADA and OTCNDA, ANDA/AADA and OTC

Dr. Basavaraj K. Nanjwade Dr. Basavaraj K. Nanjwade M. Pharm., Ph. DM. Pharm., Ph. D

Associate ProfessorAssociate ProfessorDepartment of PharmaceuticsDepartment of Pharmaceutics

KLE UniversityKLE UniversityBELGAUM – 590 010BELGAUM – 590 010

28/07/200828/07/2008 Dept. of PharmaceuticsDept. of Pharmaceutics 22

New Drug Development ProcessNew Drug Development Process


Fundamentals of NDA SubmissionsFundamentals of NDA Submissions

1.1. IndexIndex

2.2. SummarySummary

3.3. Chemistry, Manufacturing and ControlChemistry, Manufacturing and Control

4.4. Samples, Methods Validation Package and Samples, Methods Validation Package and LabelingLabeling

5.5. Nonclinical Pharmacology and ToxicologyNonclinical Pharmacology and Toxicology



6.6. Human Pharmacokinetics and BioavailabilityHuman Pharmacokinetics and Bioavailability

7. Microbiology 7. Microbiology ( for anti-microbial drugs only)( for anti-microbial drugs only)

8. Clinical Data8. Clinical Data

9. Safety Update report 9. Safety Update report ( typically submitted 120 ( typically submitted 120 days after the NDA’s submission )days after the NDA’s submission )



10. Statistical10. Statistical

11. Case Report Tabulations11. Case Report Tabulations

12. Case Report Forms12. Case Report Forms

13. Patent Information13. Patent Information

14. Patent Certification14. Patent Certification


New Drug Application (NDA) ClassificationsNew Drug Application (NDA) Classifications

1.1. New molecular entity New molecular entity

2.2. New salt of previously approved drug New salt of previously approved drug (not a (not a new molecular entity)new molecular entity)

3.3. New formulation of previously approved drug New formulation of previously approved drug (not a new salt OR a new molecular entity)(not a new salt OR a new molecular entity)

4.4. New combination of two or more drugsNew combination of two or more drugs


New Drug Application (NDA) ClassificationsNew Drug Application (NDA) Classifications

5. Already Marketed Drug Product – Duplication 5. Already Marketed Drug Product – Duplication (i.e., new manufacturer)(i.e., new manufacturer)

6. New Indication (claim) for Already Marketed 6. New Indication (claim) for Already Marketed Drug Drug ( includes switch in marketing status from ( includes switch in marketing status from prescription to OTC)prescription to OTC)

7. Already Marketed Drug Product – 7. Already Marketed Drug Product – No No previously Approved NDApreviously Approved NDA


NDA Review Process


ANDA/AADA(Abbreviated New Drug Application)

A generic drug product is one that is A generic drug product is one that is comparable to an innovator drug product comparable to an innovator drug product ( also known as the reference listed drug ( also known as the reference listed drug (RLD) product as identified in the FDA’s (RLD) product as identified in the FDA’s list oflist of Approved Drug Products with Approved Drug Products with Therapeutic Equivalence EvaluationsTherapeutic Equivalence Evaluations)) in dosage form, strength, route of in dosage form, strength, route of administration, quality, performance administration, quality, performance characteristics and intended use.characteristics and intended use.



“ “ANDA” is the abbreviation for Abbreviated New Drug ANDA” is the abbreviation for Abbreviated New Drug Application.Application.

It contains data which when submitted to FDA’s CDER, It contains data which when submitted to FDA’s CDER, office of generic drugs, provides for the review and office of generic drugs, provides for the review and ultimate approval of a generic drug product.ultimate approval of a generic drug product.

Once approved an applicant may manufacture and market Once approved an applicant may manufacture and market the generic drug product provided all issues related to the generic drug product provided all issues related to patent protection and exclusivity associated with RLD patent protection and exclusivity associated with RLD have been resolved.have been resolved.



Generic drug applications are termed Generic drug applications are termed “abbreviated” in that they are generally not “abbreviated” in that they are generally not required to include preclinical required to include preclinical (animal)(animal) and and clinical clinical (human)(human) data to establish safety and data to establish safety and effectiveness.effectiveness.

These parameters were established upon the These parameters were established upon the approval of the innovator drug product, which is approval of the innovator drug product, which is the first version of the drug product approved by the first version of the drug product approved by the FDA.the FDA.


ANDA/AADA Review Process


OTC (Over-the-Counter Drug Products)OTC (Over-the-Counter Drug Products)

Over-the Counter (OTC) drug products are Over-the Counter (OTC) drug products are those drugs that are available to consumers those drugs that are available to consumers without a prescription.without a prescription.

There are more than There are more than 8080 classes classes (therapeutics (therapeutics categories)categories) of OTC drugs, ranging from acne of OTC drugs, ranging from acne drug products to weight control drug products.drug products to weight control drug products.

There are more than There are more than 100, 000100, 000 OTC drug OTC drug products marketed, encompassing about products marketed, encompassing about 800 800 significant active ingredients.significant active ingredients.


OTC (Over-the-Counter Drug Products)OTC (Over-the-Counter Drug Products)

OTC drug monographs are a kind of OTC drug monographs are a kind of “recipe “recipe book”book” covering acceptable ingredients, doses, covering acceptable ingredients, doses, formulations and labeling.formulations and labeling.

Monographs will continually be updated adding Monographs will continually be updated adding additional ingredients and labeling as needed.additional ingredients and labeling as needed.

The newer OTC products The newer OTC products [previously available [previously available only by prescription]only by prescription] are first approved through are first approved through the NDA system and their the NDA system and their “switch”“switch” to OTC to OTC status is approved via the NDA system.status is approved via the NDA system.


OTC Drug Monograph Review Process


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development and review process of nda, anda/aada and otc

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