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Record of Telephone Conversation - TachoSil, January 22, 2010

(System Info - 123559 HE JIE 03/19/2010 11:43:59 HEJ)

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA Submission ID: 125351/0 Office: OBRR

Product: Fibrin Sealant Patch
Applicant: Nycomed Danmark ApS

Telecon Date/Time: 22-Jan-2010 10:00 AM Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
1. Advice

Author: JIE HE

Telecon Summary:
To inform Nycomed about review committee's conclusion that the ---------(b)(4)--------- ---------------- will not be approved and explained the two adminstrative options Nycomed needs to choose from.

FDA Participants:

Kimberly Lindsey, M.D. OBRR/DH/CRB

Nisha Jain, M.D. OBRR/DH/CRB

Natalya Ananyeva, Ph.D. OBRR/DH/LH

Tim Lee, Ph.D. OBRR/DH/LH

Jie He, OBRR/DBA/RPMB

Non-FDA Participants:

Kreesten Meldgaard Madsen, MD PhD, Medical Director
Gina Fischer, M.Sc. (Chem), Project Leader
Camilla Wamberg, M.Sc. (Pharm), Regulatory Affairs Manager
------------------------(b)(4)------------------------------------------- ------------------------(b)(4)---------------------------------------------------------------------------

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

The administrative options that were discussed during the Teleconference on January 22, 2010 for Nycomed’s reference.

Administrative options for Nycomed original BLA 125351.0:

FDA has reviewed the Nycomed’s responses (submitted 21 December 2009) to the Information Request of 25 November 2009 for the original BLA 125351/0 and found responses to the CMC questions and Pharmacology/Toxicology comments satisfactory. Regarding clinical aspects, Nycomed claims two indications for TachoSil under BLA 125351/0: --------------------------(b)(4)----------------------- ---------- (b) an adjunct to hemostasis in cardiovascular surgery. The review committee has concluded that the submission does not support the -(b)(4)- indication for TachoSil to the approvable level. FDA cannot approve a partial BLA submission; therefore Nycomed has two administrative options for the current BLA:

  1. If Nycomed chooses not to withdraw from consideration the -(b)(4)- indication, a Complete Response (CR) letter will be issued. When the firm responds to the CR in the future, a new 6 month review clock will be in effect. No new fees will be charged since the review will be a continuation of the review process of the original submission.
  2. Another option for Nycomed is to decouple the two indications for TachoSil and withdraw ---(b)(4)--- indication from the BLA. FDA will then continue the review of the BLA relative to the hemostasis indication only.
    • If selecting this option, Nycomed would need to submit an amendment to the original BLA that includes: 1) a cover letter stating Nycomed’s request to withdraw ---------(b)(4)----------, 2) a new Form 3567, and 3) a revised label. The revised label may be provided in a separate amendment submission, if preparation of the revision would delay the submission of the withdrawal request.
    • There is no fee associated with the withdrawal of an indication from this BLA.
    • In the future, the request for a -------(b)(4)------- for TachoSil can be resubmitted with updated data as an efficacy supplement to the original BLA. Such efficacy supplement will have a 10 month review clock. Appropriate fees apply to all efficacy supplements.

Please note that the Agency expects to be informed by Nycomed about its decision on this matter within two weeks. This time period includes submission of the revised label if option 2 is chosen by Nycomed. Please contact me with any questions regarding this BLA submission.