Ophthalmic Dosage Form Questions
Introduction:
ANDA Number
Date of Submission
Applicant’s Name
Established Name of the Drug Product
Proprietary Name of the Drug Product (include date proposed)
Labeling Submissions (proposed labeling pieces, e.g., container, carton, FPL, SPL, etc.)
QbR Questions:
Model Labeling
1. What model labeling(s) is your product labeling based upon?
USP Monograph
2. Is there a USP Drug Product Monograph, and if so, does your product’s labeling meet the USP requirements?
Patents and Exclusivities
3. 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?
4. What are the certifications and labeling impacts for each patent and exclusivity?
Inactive Ingredients
5. 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?
Manufacturing Facility
7. Who manufactures the drug product?
8. Who distributes the drug product?
Product Description
9. How does your product description in the insert labeling compare with the product description in the Finished Product Specifications?
10. How does your product description compare with the product description of the RLD?
11. Are your directions for use prominent on the container/carton labels? For example, shake well or refrigeration is required.
Container/Closure System
12. How does your proposed container/closure system differ from the container/closure system of the RLD?
13. What child-resistant feature(s) are utilized for each of your proposed packaging configurations?
14. What is the color of your cap? Do your cap color and portion of your carton/container labels comply with the Academy of Ophthalmology (AAO) for uniform color coding labels for ophthalmic drug products based on the pharmacological category?
Product Line
15. How do your package configurations compare with the package configurations of the RLD? (e.g., use of unit dose cartons).
Storage Conditions
16. How does your storage temperature statement compare with the storage temperature statement of the RLD and USP (if applicable)? Please justify the differences.
17. Is this drug product light sensitive? If yes, do the labeling recommendations and/or special packaging address light sensitivity?
Dispensing Recommendations
18. How do your dispensing recommendation statements compare with the dispensing recommendation statements of the RLD?
SPL Data Elements
19. Are the SPL Data Elements consistent with the information provided in your application and in the insert labeling?
Medwatch
20. Are the FDA Toll Free Number, MedWatch web address and manufacturer’s phone number present in the labeling?
REMS
21. Is a Risk Evaluation and Mitigation Strategy (REMS) required for the proposed product?
22. Is a non-REMS risk mitigation strategy in place for the RLD, e.g., a Riskmap?
Petitions
23. Is your proposed product subject to any petitions?
Additional Questions:
NDC Codes
1. Is your drug product registered?
2. Does your product meet the conditions of 21 CFR 207.35(b)(3)(i), regarding the proper placement of the NDC code on labeling?
Lot Numbers
3. Does a lot number, control number, or batch number appear on the label as described in 21 CFR 201.18?
Bar Coding
4. How are the conditions of 21 CFR 201.25 (Bar Code Label Requirements) met?
Over-The-Counter Products
5. How are the conditions of 21 CFR 211.132 (Tamper-evident Packaging Requirements for OTC) met?
Formatting, wording preferences
6. Do your labels and labeling meet the formatting requirements set forth in the regulations? (e.g., font size).
Medication Guides
7. How does the Medication Guide for this product differ from that approved for the RLD?
8. How will the Medication Guide be provided with the product and how many will accompany each package size?
9. Are the conditions of 21 CFR 208.20 (Content and Format of a Medication Guide) met with regard to proper Medication Guide formatting?
10. Do the proposed container labels direct the health care provider to dispense the Medication Guide as required by 21 CFR 208.24(d) (Distributing and Dispensing a Medication Guide)?
11. Have requirements for providing a toll-free number for reporting adverse events been met by including the following text with the Medication Guide?
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA 1088.
Patient Information Leaflet
12. How does the Patient Information Leaflet for this product differ from that approved for the RLD?
13. How will the Patient Information Leaflet be provided with the product and how many will accompany each package size?
14. Have requirements for providing a toll-free number for reporting adverse events been met by including the following text with the patient information?
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA 1088.
Differentiation
15. Are your product strengths sufficiently differentiated to reduce the chance of medication errors?
16. Where there is a possibility the products will be stored in close proximity, is there adequate differentiation between your proposed product and your approved products?
17. Is there sufficient contrast between the expression of strength and background color on your container labels and carton labeling?
18. Are you proposing a product with Tall Man Lettering?
Product Specific Labeling Questions
19. Does your product contain a preservative? If yes, please provide name of preservative(s) and are the preservative(s) identical to the reference listed drug?
20. Is your pH range identical to the reference listed drug?
21. Is the size of the eye dropper identical to the reference listed drug?