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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Carton Container Email, July 12, 2011 - Anascorp

Our STN:  125335/0

Rare Disease Therapeutics, Inc.
Attention:  Ms. Jennifer Spinella
July 12, 2011
By email
 
Dear Ms. Spinella:
 
We are reviewing your resubmission to your biologics license application for Centruroides (Scorpion) Immune F(ab’)2 Intravenous (Equine).  We are providing a request for revisions to your most recent version of the carton, container and content of labeling (package insert). The content of labeling is on subsequent pages. You will find both a clean copy and a track changes version of the content of labeling..
 
Container label:
  • Manufacturer and distributor information are not necessary and should be removed to allow room for the required label elements. 
  • The proper name and proprietary name should be more prominent on your container label. 
  • Please move "for intravenous use only" to a prominent location immediately under the proprietary name. Please make these words prominent in appearance.
  • Please note that NDC must appear on the upper third of the label.
  • Please add a barcode for the NDC.
  • Please change the description paragraph to read: "Contains no preservative. Sterile, nonpyrogenic, lyophilized, single use vial. Store at 25°C (77°F). Do not freeze. See package insert for dosage information."
  • Please explain the purpose of the "Anascorp L001" text in the lower right hand quadrant of the container label.
 
Carton:
  • Please move "for intravenous use only" to a prominent location immediately under the proprietary name on the front panel as well as the top panel and back panel. Please make these words prominent in appearance.
  • Please remove "10 mL vial" from the front panel.
  • Please limit the use of logos to either a single logo or omit logos altogether.
  • Please modify the first paragraph of the back panel to read "This package contains 1 vial of Anascorp. Contains no preservative. Sterile, nonpyrogenic, lyophilized, single use vial." 
 
Carton (continued)
  • Please modify the third paragraph to read "Each vial of Anascorp should be reconstituted with 5 mL of 0.9% Sodium Chloride USP (diluent not included) and mixed gently. The contents of the reconstituted vials should be further diluted in 50 mL of 0.9% Sodium Chloride USP. The reconstituted and diluted product should be used within 4 hours after reconstitution."
  • Please move the paragraph beginning "Standardized for potency…" to below the paragraph beginning "Each vial of Anascorp…" and modify the protein content to be expressed in mg/vial.
  • Please explain the purpose of the "Anascorp OU001" text in the lower right hand quadrant of the container label.
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.  Please submit your label/labeling revision as an amendment to this file, referencing the date of this request, by July 15, 2011.  Please include a revision date, version number, etc., so that we can clearly identify which version we are reviewing. Please include both a red-line strike out and clean copy of the revised package insert in WORD format. FDA is willing to accept your revised content of labeling as an email attachment, provided the attachment contains all the information that would be submitted in an amendment, i.e., Form FDA 356h, coverletter, etc. 
 
If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.
 
If we determine that your response to this information request constitutes a major amendment, we will notify you in writing. 
 
The action due date for this file is August 3, 2011.
 
If you have any questions, please contact me at (301)827-6157.
 
Sincerely,
 
 
 
Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR