Review Memo, March 28, 2014 - RAGWITEK

DEPARTMENT OF HEALTH & HUMAN SERVICES
FDA/CBER/OVRR/DVRPA

Memorandum



Date:March 28, 2014

From:Daphne D. Stewart, CSO
 Regulatory Management Support Branch,
 HFM-475, DVRPA/OVRR

Through:Laraine S. Henchal, Branch Chief, RMSB
To:BLA STN 125478/0 File

SubjectReview of Merck Sharp & Dohme Corp., BLS 125478/0 
 Immunotherapy for diagnosed ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 years of age and older for Short Ragweed Pollen Allergen Extract

Summary

Merck Sharp & Dohme Corp. has submitted a new Biologic License Application. The indication for this new product is for immunotherapy for diagnosed ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 years of age and older.

Labeling Review

Merck Sharp & Dohme Corp. has submitted the cartons and blisters labels. There were several issues 
 with the following labels:

Carton (5 tablets):

1. Why is there a Lot1 & Lot2?
 2. The NDC is missing?
 3. The "12 Amb a 1-U" should not be as prominent as the Proper Name and Trade Name?
 4. Missing barcode…although, a barcode is not required on Allergenic Products…it is on the blister label.

5. What is the actual trade name? Is it ---b(4)-------? If so, I do not think they can get away with the generic name.

6. What are all the xxxx's for?

Blister ------(b)(4)-------:

1. The NDC is missing?
 2. Missing barcode…although, a barcode is not required on Allergenic Products…it is on the blister label (F02B).
 3. The "12 Amb a 1-U" should not be as prominent as the Proper Name and Trade Name?

Carton (30 tablets):

1. Why is there a Lot1 & Lot2?
 2. The "12 Amb a 1-U" should not be as prominent as the Proper Name and Trade Name?
 3. The product code of the NDC is more prominent then the rest of the NDC.
 4. What are all the xxxx's for?

Blister ------(b)(4)-------:

1. Appears Satisfactory
 2. The "12 Amb a 1-U" should not be as prominent as the Proper Name and Trade Name?

Carton (90 tablets):

1. Why is there a Lot1 & Lot2?
 2. The "12 Amb a 1-U" should not be as prominent as the Proper Name and Trade Name?
 3. The product code of the NDC is more prominent then the rest of the NDC.

4. What is the actual trade name? Is it "Trademark™"? If so, I do not think they can get away with the generic name.

5. What are all the xxxx's for?

These labels were reviewed further for their labeler code and basic content under 21 CFR 201.57 and 21 CFR 610.61 through 21 CFR 610.67, 21CFR 201.57 and 21 CFR 207.35.

The sponsor responded to these questions in Amendment 15 dated February 4, 2014 and Amendment 21 dated March 6, 2014.

Recommendations

The cartons and blisters labels were revised and are in compliance with 21 CFR 201.57 and 21 CFR 610.61 through 21 CFR 610.67, 21CFR 201.57 and 21 CFR 207.35.

Therefore, I have determined that all comments from CBER and Merck’s response for the carton and blister labels are acceptable for approval.

Daphne D. Stewart
