Transcript Development and Review Process of NDA, ANDA/AADA

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
New Drug Development Process
28/07/2008
Dept. of Pharmaceutics
2
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
28/07/2008
Dept. of Pharmaceutics
3
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 )
28/07/2008
Dept. of Pharmaceutics
4
Fundamentals of NDA Submissions
10. Statistical
11. Case Report Tabulations
12. Case Report Forms
13. Patent Information
14. Patent Certification
28/07/2008
Dept. of Pharmaceutics
5
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
28/07/2008
Dept. of Pharmaceutics
6
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
28/07/2008
Dept. of Pharmaceutics
7
NDA Review Process
28/07/2008
Dept. of Pharmaceutics
8
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.
28/07/2008
Dept. of Pharmaceutics
9
ANDA/AADA
(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.
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.
28/07/2008
Dept. of Pharmaceutics
10
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.
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
11
ANDA/AADA Review Process
28/07/2008
Dept. of Pharmaceutics
12
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.
28/07/2008
Dept. of Pharmaceutics
13
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.
28/07/2008
Dept. of Pharmaceutics
14
OTC Drug Monograph Review Process
28/07/2008
Dept. of Pharmaceutics
15
E-mail: [email protected]
Cell No: 09448716277
28/07/2008
Dept. of Pharmaceutics
16