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ANDA Labeling
Question Based Review
September 11, 2013
GPhA/FDA ANDA Labeling Workshop/USP User Forum
Sarah Park, PharmD Jeanne Skanchy, RPh.
Labeling Reviewers
Office of Generic Drugs/Division of Labeling and Program Support
Center for Drug Evaluation and Research
Food and Drug Administration
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Labeling QbR
Questions follow the contents and flow of the
Labeling Review Template.
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Labeling Review Template
1. MODEL LABELING
2. USP & PF 3. PATENT AND EXCLUSIVITY
4. INACTIVE INGREDIENTS 5. MANUFACTURING FACILITY
6. FINISHED PRODUCT DESCRIPTION
7. S TORAGE STATEMENT AND DISPENSING RECOMMENDATIONS
8. PRODUCT LINE 9. CO NTAINER/CLOSURE 10. MEDICATION GUIDES/PATIENT PACKAGE INSERT 11. RELATED APPLICATIONS 12. SPL DATA ELEMENTS
13. CITIZEN PETITIONS/PROPRIETARY NAME/CONSULTS
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Introduction
ANDA Number ######
Date of Submission September 11, 2013
Applicant’s Name Company X
Established Name of the Drug Product Drug A Tablets USP, 20 mg
Proprietary Name of the Drug Product Name B (proposed September 11, 2013)
Labeling Submissions Container, Carton, Insert, Medication Guide, SPL
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Model Labeling
What model labeling(s) is your product labeling
based upon?
Example Answer:
RLD Drug Name, NDA 123456/S-123 approved Date
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USP Monograph
Is there a USP Drug Product Monograph? Does
your product’s labeling meet the USP
requirements?
Example Answer:
Drug X is not the subject of a USP monograph
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USP Monograph
Example Answer:
Drug X is now the subject of a USP monograph and the
official compendial name is “Drug X Tablets”. We have
included the designation “USP” in association with the
drug product name on all labeling pieces. In the insert
labeling, we have included the designation “USP” in
association with the drug product name in the TITLE,
INDICATIONS AND USAGE, DESCRIPTION and
HOW SUPPLIED/STORAGE AND HANDLING
sections.
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USP Monograph
Example Answer:
The USP 36 Drug Product Monograph states: “When
more than one Dissolution test is given, the labeling states
the Dissolution test used only if Test 1 is not used.”
Drug X utilizes Dissolution Test 2. The insert labeling
includes the statement “Meets USP Dissolution Test 2” in
the last paragraph of the DESCRIPTION section.
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USP Monograph
Example Answer:
The USP monograph for Drug X states “Preserve in well-
closed containers, protected from light.” The container
label and insert labeling include the statement “Preserve
in well-closed containers, protected from light.”
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USP Monograph
Example Answer:
The USP 36 Drug Product Monograph states: “If a test for
Organic Impurities other than Procedure 1 is used, then
the labeling states with which Organic Impurities test the
article complies.”
Company X’s Drug A complies with Procedure 2. The
insert labeling includes that statement “Meets Organic
Impurities Test Procedure 2” in the last paragraph of the
DESCRIPTION section.
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Patents and Exclusivities
What are the currently approved patents and
exclusivities for the reference listed drug as listed
in the Approved Drug Products with Therapeutic
Equivalence Evaluation (Orange Book), and what
impact do they have on the labeling submitted?
What are the certifications and labeling impacts
for each patent and exclusivity?
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Patents and Exclusivities
Example Answer:
Patent Data:
Appl No Prod No Patent No Patent
Expiration
Patent Use
Code
Patent
Certification
Labeling
Impact
N###### 001 ####### Sep 1, 2021 U - #### PIV Carved out
Code Definition
U - ####
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Patents and Exclusivities
Example Answer:
Exclusivity Data:
Appl No Prod No Exclusivity
Code
Exclusivity
Expiration
Exclusivity
Statement
Labeling
Impact
N###### 001 NPP Mar 1, 2016 Will not market
until expiry
None
N###### 001 PED Sep 1, 2016
Code Definition
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Inactive Ingredients
Is the listing of inactive ingredients in the
DESCRIPTION section of the package insert
consistent with the listing of inactive ingredients
found in the statement of components and
composition and SPL data elements?
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Inactive Ingredients
Example Answer:
The listing of inactive ingredients in the DESCRIPTION
section of the package insert is consistent with the listing
of inactive ingredients found in the statement of
components and composition appearing in section 3.2.P.1.
and SPL data elements.
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Inactive Ingredients
Do any of your inactive ingredients require
special labeling statements or have regulatory
requirements?
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Inactive Ingredients
Example Answer:
Elemental Iron:
The 20 mg tablet contains red and black iron oxides.
(Show calculations.)
The total daily amount of elemental iron in the 20 mg
tablet is #.## mg. Company X confirms that the maximum
daily intake of elemental iron from the tablets based on
the maximum recommended daily dosage of the drug
product is less than 5 mg per day as per 21 CFR 73.1200.
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Manufacturing Facility
Who manufactures the drug product?
Example Answer:
Manufacturing Facility Name
Facility address
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Manufacturing Facility
Who distributes the drug product?
Example Answer:
Distributor Name
Distributor Address
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Product Description
How does your product description in the insert
labeling compare with the product description in
the Finished Product Specifications?
How does your product description compare
with the product description of the RLD?
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Product Description
Example Answer:
Finished Product
Specifications:
White, capsule shaped, biconvex, film-coated tablets
debossed with “XX ##” on one side and plain on
other side.
ANDA insert:
Drug A tablets are white, capsule shaped, biconvex,
film-coated tablets debossed with “XX ##” on one
side and plain on the other side.
RLD:
NDA Drug C tablets are white, capsule-shaped, film-
coated, debossed with “X##” on one side and plain-
faced on the other side.
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Product Description
How does your product’s dimensions compare
with the dimensions of the RLD tablet?
Example Answer:
RLD Tablet Size ANDA Tablet Size
75 mg 9 mm 9 mm
150 mg 14 mm 15 mm
300 mg 17 mm 17 mm
400 mg 19 mm 19 mm
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Product Description
How are the conditions of 21 CFR 206
(Imprinting of Solid Oral Dosage Form) met?
Example Answer:
The tablets have been accurately described in the HOW
SUPPLIED section as required by 21 CFR 206,et al.
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Product Description
Is the RLD tablet strength linked to or generally
recognized by tablet color?
Example Answer:
The RLD tablet strengths are linked to or generally
recognized by tablet color.
The tablet colors of our XXX tablets corresponds to the
tablet colors of the RLD drug product.
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Product Description
RLD ANDA
1 mg Pink Pink
2 mg Lavender Lavender
2.5 mg Green Green
3 mg Tan Tan
4 mg Blue Blue
5 mg Peach Peach
6 mg Teal Teal
7.5 mg Yellow Yellow
10 mg White White
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Storage Conditions
How does your storage temperature statement
compare with the storage temperature statement
of the RLD and USP (if applicable)? Please
justify the differences.
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Storage Conditions
Example Answer:
USP: Store between 15
and 25
C. Protect from light
and moisture.
RLD: Store at 15
to 25
C (59
to 77
F) and protect
from moisture.
ANDA: Store at 20
to 25
C (68
to 77
F). [See USP
Controlled Room Temperature.] Protect from light
and moisture.
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Storage Conditions Is this product light sensitive? If so, do the storage
recommendations and/or special packaging
address light sensitivity?
Example Answer:
The drug product is light sensitive.
The labels and labeling include the statement “Protect
from light.”
The bottles meet requirements for light transmission
per USP <661> .
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Dispensing Recommendations
How do your dispensing recommendation
statements compare with the dispensing
recommendation statements of the RLD?
Example Answer:
RLD: Dispense in original container.
ANDA: Dispense in original container.
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Product Line
How do your packaging configurations compare
with the packaging configurations of the RLD?
Example Answer:
Please provide a table to include the packaging
configurations for the RLD and ANDA.
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Container & Closure System
How does you proposed container/closure system
differ from the container/closure system of the
RLD?
What child-resistant feature(s) are utilized for each
of your proposed packaging configurations?
Example Answer:
Please provide a table to include the container/closure
system of the RLD and ANDA for comparison.
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Container & Closure System
Is your drug product a controlled substance? If
yes, does the labeling meet the regulatory
requirements of 21 CFR 1302.06 for tamper-
evident sealing?
Example Answer:
Please provide a statement that your drug product
meets the requirements of 21 CFR 1302.06 for
tamper-evident sealing.
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Medication Guides
How will the Medication Guide be provided with
the product and how many will accompany each
package size?
Example Answer:
In accordance with 21 CFR 208.24 (b), a
sufficient number of the Medication Guides is
available for distribution to each patient receiving
a prescription for the drug product.
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Medication Guides Do the proposed container labels and carton labeling
direct the health care provider to dispense the
Medication Guide as required by 21 CFR 208.24 (d)
(Distributing and Dispensing a Medication Guide)?
Example Answer:
Yes, the proposed container labels and carton
labeling direct the health care provider to dispense
the Medication Guide as required by 21 CFR
208.24 (d).
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Medication Guides The Agency recommends that you include one of
the following pharmacist dispensing statements:
“Pharmacist: Dispense the enclosed Medication
Guide to each patient.” or
“Pharmacist: Dispense the accompanying
Medication Guide to each patient.” or
“Pharmacist: Dispense the Medication Guide
provided separately to each patient.”
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Medication Guides Is there an FDA toll-free number for reporting
adverse events under “What are the possible side
effects?” in the Medication Guide?
Example Answer:
Yes, an FDA toll-free number for reporting
adverse events under “What are the possible
side effects?” has been provided.
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Related ANDAs Are there any related ANDAs for your drug
product? Yes or No
Example Answer:
If yes, then list any pending and approved
ANDAs that contain the same drug product with
different dosage forms.
If no, then provide a statement that there are no
related ANDAs for the drug product.
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Structured Product Labeling (SPL)
Are the structured product labeling (SPL) data
elements consistent with the information
provided in your application and the insert
labeling?
Example Answer:
Yes, please state that the SPL data elements
are consistent with the information provided
in the application and insert labeling.
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Citizen Petitions
Is your proposed drug product subject to any
pending Citizen Petitions (CP)? Yes or No
Example Answer:
If yes, please state that the drug product is
subject to a pending Citizen Petition. Please
explain or list the CP.
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Disclaimer:
This presentation reflects the views of
the authors should not be construed to
represent FDA’s views or policies.
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Thank You!