PERIODIC ADVERSE DRUG EXPERIENCE

REPORT

Product Name, Strength

ANDA/NDA/NDC/BLA Number:XXXXXX

ANDA/NDA/NDC/BLA Approval date: MM/DD/YYYY

Reporting Period: MM/DD/YYYY to MM/DD/YYYY
Report Status: Annual/Quarterly
Date of Report: MM/DD/YYYY

Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.

Address:

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Annual /Quarter PADER(**st/nd/rd/th) Reporting Period: MM/DD/YYYY to MM/DD/YYYY
Product Name, Strength ANDA/NDA/NDC/BLA XXXXXX

TABLE OF CONTENTS:

1. NARRATIVE SUMMARY AND ANALYSIS OF INFORMATION IN THE REPORT ....................... 3

1.1 Summary Overview: ............................................................................................................................. 3
2. Analysis of the 15-Day Alert Reports:......................................................................................................... 34
2.1. Line listing of the 15-day reports submitted during the reporting period: .................................................. 4
2.2. Cases sent as FDA 3500As under another ANDA: ............................................................................. 45
2.3. Summary Tabulations by Body System (System Organ Class) of 15-Day and non 15-day reports ..... 5
3. HISTORY OF ACTIONS TAKEN ........................................................................................................... 7
4. INDEX LINE LISTING ............................................................................................................................ 7
5. FDA FORM 3500A FOR NON-EXPEDITED REACTIONS .................................................................. 8

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Annual /Quarter PADER(**st/nd/rd/th) Reporting Period: MM/DD/YYYY to MM/DD/YYYY
Product Name, Strength ANDA/NDA/NDC/BLA XXXXXX

1. NARRATIVE SUMMARY AND ANALYSIS OF INFORMATION IN THE REPORT

1.1 Summary Overview:

This report is the <First Quarterly/Annual> Periodic Adverse Drug Experience Report (PADER)
for <Drug Name> which was approved for under ANDA/NDA/NDC/BLA Number: <XXXXXX>
as <Formulation and Strength> on <MM/DD/YYYY>. This report summarizes the safety data
received by Luoxin, from <MM/DD/YYYY> to <MM/DD/YYYY>.
For tabulation by System Organ Class of all events coded as per MedDRA Version___. See the
tables located in section 1.5 titled
“Tabulations by System Organ Class of 15-Day and non-15Day reports.”

This PADER report includes ___total number of cases and ___total number of events [number of
15-day reports (serious unlisted from all sources) submitted and number of non-15day reports
(domestic spontaneous, serious listed, non-serious unlisted and listed)] were received during this
period.

15 Day Alert Reports:

_____ serious unlisted initial and follow-up case report from all sources submitted to the FDA as
15-day alert reports.

Non-15 Day reports:

_____ non-15-day alert reports (serious listed, non-serious unlisted and listed) whether Initial or
follow-up from sources domestic spontaneous.

2. Analysis of the 15-Day Alert Reports:

During this period from ________ to ________, <Luoxin> had submitted________ serious
unlisted case reports. These reviews were divided into
a) Initial case reports___ and
b) follow-up case reports___.
Note: If no follow up 15-day alert reports are available, remove above statement.

Initial 15-Day Alert Reports:

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 Annual /Quarter PADER(**st/nd/rd/th) Reporting Period: MM/DD/YYYY to MM/DD/YYYY
Product Name, Strength ANDA/NDA/NDC/BLA XXXXXX

Mfr No/Case No: ________

Narrative Summary:________

Clinical Discussion ________

Follow-up 15-Day alert Reports:

Mfr No/Case No: ________

Narrative Summary:________

Clinical Discussion ________

2.1 Line listing of the 15-day reports submitted during the reporting period:

Date sent
Age/ Sex

Outcome
Reported
duration
Treatme
Country

MedDRA

Type of

to FDA
Date of
Source
Report

(version)
Daily

event

event
ADR
dose
No

version
nt

PT

2.2 Cases sent as FDA 3500As under another ANDA:

During the reporting period of this PADER, where product XXXX (ANDA/NDA//NDC/BLA:
xxxxx) was one of the suspect drug but the cases were submitted for another Luoxin or its

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Annual /Quarter PADER(**st/nd/rd/th) Reporting Period: MM/DD/YYYY to MM/DD/YYYY
Product Name, Strength ANDA/NDA/NDC/BLA XXXXXX

subsidiary ANDA/NDC number suspect drug. The ANDA/NDC number of the primary suspect
drug along with the manufacturer control numbers are mentioned below:

Date of Mfr.Control Number/Case

ANDA/NDA/NDC/BLA
Submission to ID/Transmission ID
number
FDA

2.3 Summary Tabulations by Body System (System Organ Class) of 15-Day and non15-day
reports

Summary of PTs describing different event reactions with product ________ is presented below.

Table 1: Serious, Unexpected Events:

SOC MedDRA Preferred term (Version) Number of events

Total Number of Events

Table 2: Serious, Expected Events:

SOC MedDRA Preferred term (Version) Number of events

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Annual /Quarter PADER(**st/nd/rd/th) Reporting Period: MM/DD/YYYY to MM/DD/YYYY
Product Name, Strength ANDA/NDA/NDC/BLA XXXXXX

Total Number of Events

Table 3: Non-serious, Unexpected Events:

SOC MedDRA Preferred term (Version) Number of events

Total Number of Events

Table 4: Non-serious, Expected Events:

SOC MedDRA Preferred term (Version) Number of events

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Annual /Quarter PADER(**st/nd/rd/th) Reporting Period: MM/DD/YYYY to MM/DD/YYYY
Product Name, Strength ANDA/NDA/NDC/BLA XXXXXX

Total Number of Events

For tabulation by System Organ Class of all events, see the tables located in section 2.3 titled
“Tabulations by System Organ Class of 15-Day and non-15-Day reports”

3. HISTORY OF ACTIONS TAKEN

During this reporting period from ________ to ________, <Luoxin> has/has not received any
adverse drug experiences which relates to the product labeling changes or studies initiated or
foreign regulatory actions or any other communications.

Conclusion: ________

4. INDEX LINE LISTING

Information from the FDA Form 3500 As included in this report is contained in this section.
“_____ Non-15 Day reports (domestic spontaneous serious listed, non-serious listed and non-
serious unlisted)” were received by < Luoxin > and included during the period from ________ to
________.

Table 5:

Number of
Report Type
Reports

Spontaneous domestic Serious listed

Spontaneous domestic Non-serious unlisted

Spontaneous domestic Non-serious listed

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Annual /Quarter PADER(**st/nd/rd/th) Reporting Period: MM/DD/YYYY to MM/DD/YYYY
Product Name, Strength ANDA/NDA/NDC/BLA XXXXXX

5. FDA FORM 3500A Acknowledgement numbers/E2B FORM Acknowledgement

numbers FOR NON-EXPEDITED REACTIONS

During the reporting period from ________ to ________, there were __ ADE report received from
US that did not meet the criteria for reporting to FDA as 15-day alerts as per 21 CFR 314.80.
Luoxin successfully submitted this non-15day ICSRs electronically to the FDA via ESG on DD-
MMM-YYYY.

Details as presented below:

Mfr.Control Number/Case ID/Transmission ID Date of Submission to FDA

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