Date: June 26, 2009
From: Loan Nguyen, Pharm.D, Regulatory Review Officer
Through: Ele Ibarra-Pratt, RN, MPH, Branch Chief
To: Darlene Hithe, RPM, OVRR/DVRPA/VVB (HFM-478)
Daryll Miller, Committee Chair, OVRR/DVRPA/CMC1 (HFM-478)
Lewis Schrager, Medical Officer, OVRR/DVRPA/CRB1 (HFM-475)
Subject: Comment on the product name
Amendment submitted June 10, 2009
Product: Adenovirus Type 4 and Type 7 Vaccines, Live, Oral
BLA STN: 125296/0
Sponsor: Duramed Research Inc. (a subsidiary of Barr Pharmaceuticals Inc.)
On September 30, 2008, Duramed Research Inc. (Duramed) submitted BLA STN 125296/0 for adenovirus type 4 and type 7 vaccines, live, oral, enteric coated tablets.
On February 19, 2009, the sponsor submitted a request for a review of the proposed proprietary name, ---(b)(4)---. Since ---(b)(4)--- was considered to be fanciful and there was potential significant risk for medication errors with the proprietary names of other currently marketed products, APLB recommended that the proposed proprietary name ---(b)(4)--- be found unacceptable (see memo dated March 31, 2009 for details).
The unacceptability of the proposed proprietary name was communicated to Duramed on May 4, 2009. On June 10, 2009, Duramed submitted an amendment to the application to withdraw the proposed proprietary names, ---(b)(4)--- and ---(b)(4)---, and to proceed using the proper name.
Duramed also submitted with the amendment the draft product labelings (full prescribing information and carton and bottle labels) to reflect this change. On the updated draft labelings, the sponsor used “Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, Enteric Coated Tablets for Oral Administration” as the product name.
The use of “Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, Enteric Coated Tablets for Oral Administration” as the product name is a concern. Since “Enteric Coated Tablets” is the dosage form and “for Oral Administration” is the route of administration, “Enteric Coated Tablets for Oral Administration” should not be presented as part of the product name. We recommend that the sponsor separate the dosage form and route of administration from the product name or final proper name and revise the proposed labelings accordingly.
If you have any questions with regards to this review please contact Loan Nguyen, Pharm.D, Regulatory Review Officer at 301-827-3028.