Date: March 7, 2008
Nisha Jain, OBRR/DH/LBVB, HFM-343
Pratibha Rana, OBRR/DBA/RPMB, HFM-380
Maryann Gallagher, Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB)
Division of Case Management (DCM), HFM-602
Ele Ibarra-Pratt, RN, MPH, Branch Chief, APLB, DCM, HFM-602
Robert A. Sausville, Director, DCM, HFM-610
Review of proposed proprietary name ATryn (Antithrombin alfa)
(BB-IND -b(4)-) , STN 125284/0
APLB recommends that the proposed proprietary name ATryn be found Acceptable with concerns.
On August 9, 2007, GTC Biotherapeutics submitted a pre-BLA Information Package for ATryn (antithrombin alfa), which included a request to review their proposed proprietary name. The submission was received in the CBER Document Control Room on August 9, 2007 and in APLB on October 2, 2007.
ATryn® has been registered as a trademark with the U.S. Patent and Trademark Office since April 9, 2002.
Overview of the Proposed Indication, Dose, Dosage Form, Administration, and Storage Information:
ATryn is designated as an orphan drug for the treatment of patients with hereditary antithrombin deficiency. The proposed indication for ATryn is for the prevention of peri-operative and peri-partum thromboembolic events, as well as the treatment of patients with hereditary antithrombin deficiency during surgical or obstetrical procedures to reduce the risk of thromboembolism. ATryn is a lyophilized powder containing nominally 1750 IU antithrombin alfa per vial. A vial of lyophilized ATryn is reconstituted with 10mL of Sterile Water for Injection (WFI) to provide approximately a 175 IU/mL solution, which is intended for intravenous infusion. The reconstituted product may be diluted further with 0.9% sodium chloride solution to desired antithrombin concentration and added to an IV infusion bag or infusion pump for intravenous infusion. The loading dose will be determined on an individual basis depending upon patient pre-treatment AT activity levels, patient body weight and taking into consideration usage of concomitant medications. Likewise, the dose for continuous infusion will be based upon patient pre-treatment AT activity level and body weight. Dosage during continuous infusion may be adjusted based upon rate of consumption and medical conditions. Dose adjustments may be made by administration of a short bolus dose or by increasing the rate of continuous infusion. Therapeutic drug monitoring recommendations will be made in the proposed package insert based upon recommendations used in clinical trials.
The lyophilized kit may be stored in a refrigerator (2°-8°C). ATryn will be provided as a sterile lyophilized product packaged in 20mL glass vials. ATryn should be reconstituted and administered within 12 hours in the hospital.
The company’s rationale for selecting the proposed proprietary name ATryn:
AT is a common abbreviation for the active moiety (antithrombin)
Try means three to represent the active moiety antithrombin III.
GTC Biotherapeutics had a full pharmaceutical trademark research study carried out by --b(4)-----------------, to ensure that the proposed tradename ATryn has not already been chosen for a product and to ensure that there are no sound-alike or look-alike names. GTC Biotherapeutics is in the process of updating their search by using the reference texts listed in Appendix 2 in the FDA SOPP 8001.4, to further evaluate their proposed proprietary name. The study will be submitted upon completion.
Proposed Proprietary Name Evaluation:
- False or Misleading [21 CFR 201.6 (a)]:
The proposed proprietary name ATryn is not regarded to be false or misleading.
- Fanciful [21CFR 201.10 (c)(3)]:
The proposed proprietary name ATryn is not regarded to be fanciful. It does not appear to imply that the drug or ingredient has some unique effectiveness or composition beyond that supported by the data.
- Similarity in Spelling or Pronunciation [21 CFR 201.10 (c) (5)]:
Drug products are prescribed through written, verbal, and /or electronic orders. Such forms of communication may lead to medication errors, particularly if proprietary and /or established names sound or look alike. Even when proprietary names are only slightly similar, overlapping product characteristics may create a greater potential for confusion.
- Atropine may be confused with the proprietary name ATryn because the first three letters (Atr) could be potentially confused with the first three letters in ATryn in verbal orders but Atropine has 3 syllables and ATryn has 2 syllables. In addition, Atropine and ATryn have different indications, i.e. Atropine is an anticholinergic used as a premedication for anaesthesia, to treat bradycardias, and during reversal of neuromuscular blockade in adults. Atropine will be stored at room temperature in all hospital pharmacies; however, ATryn will be stored refrigerated and because it is an orphan drug, it will not be routinely stored in all pharmacies. Therefore, this may minimize the risk of medication error between ATryn and Atropine. However, both products may be used under similar settings and surgical procedures, which may increase the risk for medication error.
- Afrin may be confused with the proprietary name ATryn because of similarity in spelling, pronunciation, and handwriting. Afrin and ATryn have different indications and Afrin is an over the counter drug and does not require a prescription. ATryn is an orphan drug available by prescription for a specific indication and population, and will not be routinely stored in all pharmacies. Therefore, there the risk of medication error between ATryn and Afrin is minimized.
Recommendations for proposed name:
APLB recommends that the proposed proprietary name ATryn be found acceptable with concerns. There appears to be a minimal risk for medication errors with the proprietary names for other marketed products taking into account similarity in spelling, therapeutics class, indication, pronunciation, handwriting and marketing status. If OBRR accepts our recommendation that the proposed proprietary name ATryn be found acceptable with concerns, please include the following text in your letter to the manufacturer:
We have considered your proposed proprietary name ATryn in consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) and conclude that under 21 CFR Part 201 the proposed proprietary name is acceptable at this time.
You should request another proprietary name review of ATryn closer to the time of approval since a significant amount of time may pass between now and licensure of the product and to ensure that FDA has not approved a product with a conflicting proprietary name in the interim.
If you have any questions regarding this review, please contact Maryann Gallagher at 301-827-3028.
The following references were used:
- http: //www.thomsonhc.com/pdrel/librarian (Electronic Physicians’ Desk Reference 2007)
- http://www.factsandcomparisons.com (Drug Facts and Comparisons)
- http:// www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (CDERNew and Generic Drug Approvals through October 31, 2007)
- http://www.fda.gov/cder/ob (Electronic Orange Book through October 17, 2007)
- http://www.rxlist.com (RxList)
- http://www.fda.gov/cber/products/htm (CBER New BLA, 510 (k) Devices, NDA and PMA approvals lists through October 31, 2007)
- http://www.ama-assn.org/ama/pub (American Medical Association Website-Newly Approved USAN stems through October 5, 2007
- http: //www.acronymfinder.com
- 2007 American Drug Index.