ANDA Labeling Question Based Review September 11, 2013 GPhA/FDA ANDA Labeling Workshop/USP User Forum

Transcription

1 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 1

2 Labeling QbR Questions follow the contents and flow of the Labeling Review Template. 2

3 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 3

4 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 4

5 Model Labeling What model labeling(s) is your product labeling based upon? Example Answer: RLD Drug Name, NDA /S-123 approved Date 5

6 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 6

7 Example Answer: USP Monograph 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. 7

8 Example Answer: USP Monograph 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. 8

9 Example Answer: USP Monograph The USP monograph for Drug X states Preserve in wellclosed containers, protected from light. The container label and insert labeling include the statement Preserve in well-closed containers, protected from light. 9

10 Example Answer: USP Monograph 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. 10

11 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? 11

12 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 - #### 12

13 Patents and Exclusivities Example Answer: Exclusivity Data: Appl No Prod No Exclusivity Code Exclusivity Expiration Exclusivity Statement N###### 001 NPP Mar 1, 2016 Will not market N###### 001 PED Sep 1, 2016 until expiry Labeling Impact None Code Definition 13

14 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? 14

15 Example Answer: Inactive Ingredients 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. 15

16 Inactive Ingredients Do any of your inactive ingredients require special labeling statements or have regulatory requirements? 16

17 Example Answer: Elemental Iron: Inactive Ingredients 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

18 Manufacturing Facility Who manufactures the drug product? Example Answer: Manufacturing Facility Name Facility address 18

19 Manufacturing Facility Who distributes the drug product? Example Answer: Distributor Name Distributor Address 19

20 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? 20

21 Example Answer: Product Description Finished Product Specifications: ANDA insert: RLD: White, capsule shaped, biconvex, film-coated tablets debossed with XX ## on one side and plain on other side. Drug A tablets are white, capsule shaped, biconvex, film-coated tablets debossed with XX ## on one side and plain on the other side. NDA Drug C tablets are white, capsule-shaped, filmcoated, debossed with X## on one side and plainfaced on the other side. 21

22 Product Description How does your product s dimensions compare with the dimensions of the RLD tablet? Example Answer: RLD 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 ANDA Tablet Size 22

23 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. 23

24 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. 24

25 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 25

26 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. 26

27 Example Answer: Storage Conditions 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. 27

28 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>. 28

29 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. 29

30 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. 30

31 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. 31

32 Container & Closure System Is your drug product a controlled substance? If yes, does the labeling meet the regulatory requirements of 21 CFR for tamperevident sealing? Example Answer: Please provide a statement that your drug product meets the requirements of 21 CFR for tamper-evident sealing. 32

33 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 (b), a sufficient number of the Medication Guides is available for distribution to each patient receiving a prescription for the drug product. 33

34 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 (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 (d). 34

35 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. 35

36 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. 36

37 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. 37

38 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. 38

39 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. 39

40 Disclaimer: This presentation reflects the views of the authors should not be construed to represent FDA s views or policies. 40

41 Thank You! 41