This document discusses 505(b)(2) new drug applications (NDAs) to the FDA. 505(b)(2) NDAs contain the same active ingredient as a previously approved drug but require full safety and effectiveness reports. They allow applicants to avoid duplicating studies already performed for the original drug. This pathway is less expensive and faster than a traditional 505(b)(1) NDA because it relies on existing knowledge of the drug's safety and efficacy. Examples of changes that can be approved via 505(b)(2) include new indications, formulations, dosages, and combinations. The document also provides an overview of how to navigate the 505(b)(2) approval process.

1. PRESENTED BY :
AMOL P.SATPUTE
ROLL NO.22162007
M.PHARM 1st YEAR (2nd sem)
GUIDED BY:
DR.M.S. MUTHU SIR
ASSOCIATE PROFESSOR
DEPARTMENT OF PHARMACEUTICAL
ENG.& TECHNOLOGY

2. WHAT IS 505(b)(2)
The 505(b)(2) is the new drug application (NDA) to food and drug
administration (FDA) for drug approval . This type of application contain
same active ingredient as previously approved drug .
The pathway was created by the Hatch-Waxman amendment of 1984 it help
to prevent the duplication of studies already performed on previously
approved drug .
505(b)(2) contains full safety and effectiveness reports required for NDA
approval but such studies not conducted by applicant .
Hence the 505(b)(2) application is much less expensive & much faster rout
to approval compared with 505(b)(1).
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3. EXAMPLES OF 505(b)(2) NDA
New chemical entity
Changes compared to previously approved drugs
Indication
Active ingredient
Fixed combination
Dosage form
Route of administration
Dosing regimen
Strength
Formulation ( not approvable under section 505(j))
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4. NAVIGATING THE 505(B)(2)
APPROVAL PATHWAY
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5. 505(J) ANDA APPLICATION
Abbreviated new drug application (ANDA) contain data
which submitted to FDA for approval of generic drug
product.
The Hatch – Waxman act 1984 related to approval of
generic drug manufacturing from FDA .
Generic drug product are compare to brand/ RLD
product in dosage form , strength , ROA , quality , and
intended use .
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6. ANDA CERTIFICATE
CLAUSE
PARAGRAPH
I
PARAGRAPH
II
PARAGRAPH
III
PARAGRAPH
IV
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7. PARA IV
CERTIFICATION
After 45 days patent
holder doesn’t sue
applicant FDA may
approve ANDA
ANDA applicant
granted
approval
After 45 days patent
holder sues the applicant
30 months stay granted
to patent holder
30 month
stay expires
For the first
applicant the
EMR of 180
days start with
courts
decision
Subsequent
approval for EMR
are granted after
expiry of first
applicant 180
days
30 months stay not
expired
If judgement in
favour of patent
holder FDA can not
approve ANDA until
patent expiry.
No entry occurs
until patent
expiry.
Judgement
favouring ANDA
EMR of 180 days
beings for first
applicant.
First applicant
enters ,
subsequent
applicant
enter only
after expiry of
EMR for the
first applicant.
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8. 7
ANDA REVIEW PROCESS

9. NON PATENT EXCLUSIVITY IN THE
USA
1. Orphan drug entity 7 year
2. New chemical entity 5 year
3. New clinical study exclusivity 3 year
4. Pediatric drug exclusivity 6 month
5. Patent challenges (ANDA only) 180 days
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