3/5/2008 Email - Rotarix

From:	Henchal, Laraine
Sent:	Wednesday, March 05, 2008 10:43 AM
To:	'Donna.2.Boyce@gsk.com'
Cc:	Vujcic, Luba
Subject:	Comments on Lot Release Protocol (if you have not already been coordinating these with Joe Quander)

License Name of the Product is listed as "Rotavirus Vaccine, Live, Oral, Monovalent" in the RMS/BLA, the firm is using "Rotavirus (89-12) Live Attenuated Oral Vaccine" The firm needs to fix the LRP. Replace "STN - 125265 / 1617 / FC" with "cc: 125265_0 / 1617 / FC"" at the top of each page. One page one the term "Protocol for:" needs to be changed to "Reason for Submission" Sterility data need to be in its table format.

Method used:

On Test Date   Medium/Temperature   Off Test Date

If firm intends to submit the Lot Release Protocol as electronic they need add the Electronic Protocol filename at the bottom of page one. Also the document must be searchable and not static like an image.

Comments on Container/Carton labels:

Please add bar code to diluent label. If you are considering ------------------------------------------------------------, we will need to see a -------- label for that.

Comment on Proprietary Name:

We have considered your proposed proprietary name Rotarix in consultation with CBER's Advertising and Promotional Labeling Branch and conclude that under 21 CFR Part 201 the proposed proprietary name is acceptable.

That's it for now. I am sure there will be more to come.

Laraine S. Henchal, MAS
Microbiologist Reviewer, Team Leader
Viral Vaccines Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Phone: 301-827-3070
Fax: 301-827-3532