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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Mid Cycle Review Memo - EVARREST

To: Administrative File, STN 125392/0 for Fibrin Pad

From: Randa Melhem, Ph.D., OCBQ, DMPQ, MRBII, HFM-676
Nancy Waites, OCBQ, DMPQ, MRBI, HFM-675
Through: Chiang Syin, Ph.D., Branch Chief, OCBQ, DMPQ, MRB II, HFM-676

Subject: Mid Cycle Review Memo (BLA): [Omrix Biopharmaceuticals Ltd. License No. 1603]: Original BLA to get approval for Fibrin Pad, a sterile bio-absorbable combination product intended for use as an adjunct to hemostasis for soft tissue bleeding. The final Fibrin Pad product is manufactured at Omrix Fibrin Pad Production Facility (FPPF) in Nes-Ziona, Israel

Action Due: September 19, 2011

Action Recommended:

Summary / Background
CBER received this electronic submission on November 19, 2010. Omrix Biopharmaceuticals Ltd. (Omrix) submitted a BLA to get approval for Fibrin Pad, a sterile bio-absorbable combination product made from a flexible composite Matrix (device component) coated with Human Fibrinogen and Human Thrombin plasma-derived proteins (biological drug substances). Fibrin Pad is intended for use as an adjunct to hemostasis for soft tissue bleeding during retroperitoneal, intra-abdominal, pelvic, and (non-cardiac) thoracic surgery when control of bleeding by standard surgical methods of hemostatis is ineffective or impractical.

Drug Substance (DS)
Human Fibrinogen drug substance [also referred to as --------------------------(b)(4)-------------------- is a concentrate of -------(b)(4)------ plasma proteins, which consists principally of fibrinogen, but also contains --------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------.
Human Thrombin drug substance includes a combination of ------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------.
The Human Thrombin and Human Fibrinogen are manufactured --------------------------------------------------------------------------(b)(4)--------------------------------------------------------.

Device
The Matrix device component of the Fibrin Pad is a flexible composite Matrix. This composite Matrix is composed of polyglactin 910 (PG910) and oxidized regenerated cellulose (ORC). The Matrix has off-white to yellowish appearance, with an embossed wave pattern present on the knitted ORC surface. The Matrix size is 4 x 4 in. (10.2 x 10.2 cm), with a thickness of approximately 2 mm. The Matrix is considered to be an implant with “permanent” tissue contact for greater than 30 days, up to the point when the implant is expected to be absorbed at 56 days post-implantation.
The Matrix is manufactured at ------------------------(b)(4)----------------------------.

Drug Product
The current process for the manufacture of Fibrin Pad includes --------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------, followed by --------------------------------(b)(4)-----------------------------------. Application of the -----(b)(4)----- is then performed by ---------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------- onto Polyglactin 910 (PG910) side of the embossed Matrix ------(b)(4)------. This is followed by -----------(b)(4)------------- is terminally sterilized by e-beam irradiation. The unopened Fibrin Pad is intended to be stored inside the foil pouch at controlled room temperature for up to (b)(4) months.
The Fibrin Pad product is manufactured at Omrix Biopharmaceuticals Ltd., Fibrin Pad Production Facility (FPPF) in Nes-Ziona, Israel, and ------------------------------------------------(b)(4)---------------------------------------------.

Letter Ready Questions

Shipping Validation

  1. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.
  2. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------ -------------------------.
  3. --------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------

2 pages redacted (b)(4)