RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125392/0.30 Office: OBRR
Fibrin Sealant Patch [EVARREST]
Telecon Date/Time: 26-Oct-2012 10:00 A.M. Initiated by FDA? Yes
1. Other – Internal Meeting
Author: TRACY TILGHMAN
Discussion of the revised labeling for EVARREST Fibrin Sealant Patch submitted by Ethicon in response to the Complete Response (CR) letter dated September 28th, 2012.
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
The purpose of this internal meeting was to discuss the revised text of Prescribing Information and the package label for EVARREST Fibrin Sealant Patch submitted by Ethicon in response to the CR letter dated September 28th, 2012. The information below summarizes the recommendations of the review team for the text of the PI and the package label.
Use of Trademark EVARREST ™
To minimize the use of trademark (TM) throughout the text of Prescribing Information as it dilutes the message. The use of EVARREST TM at the first mentioning in a section is sufficient.
1 Indications and Usage (under Highlights and Full Prescribing Information)
To revise the sentence as follows: “EVARREST TM is a fibrin sealant patch indicated for …”. According to 21 CFR 201.57(a)(6), the first mentioning of the product (EVARRESTTM) requires defining its pharmacological class (fibrin sealant patch). The name of class serves as a standardized tool for Metadata search capabilities. This will also be consistent with Prescribing Information for other Ethicon’s products, EVITHROM and EVICEL.
Limitations of Use
Recommend bulleted presentation and use of directive language.
Recommend modifying the subtitle by additional words “soft” and “bleeding”: Apply on the surface of soft tissue bleeding only.
6 Adverse Reactions
List adverse reactions in one sentence in the preamble.
· Delete the following sentence as redundant “Any event that was reported at least once as an adverse reaction, where the percentage was greater for the treated subjects as compared to the control subjects, is described in Table 1”.
Add “across all clinical trials involving 243 subjects” to emphasize that the safety data from all clinical studies (efficacy and additional) was taken into consideration.
· Revise the title of Table 1: Adverse Reactions Reported in Clinical Trials
Change “adjacent to” to “underlying”: “The patch component of EVARRESTÔ consists of an oxidized regenerated cellulose (ORC) layer underlying a layer of polyglactin 910 (PG910) non-woven fibers”.
6 Adverse Reactions and 14 Clinical Studies
Demographic information is not necessary because it does not add clinical meaningfulness.
17 Patient Counseling Information
Use command language;
Remove the date from bottom of PI; the date is stated on p. 1.
Recommendations to the package label are for Ethicon’s consideration only.
To send the annotated version of the PI with FDA editorial changes and FDA recommendations for the package label to Ethicon for revision of the PI and the package label (respective files are attached to this record).
Per Ethicon’s request, to schedule a teleconference for the following week of October 29th, 2012 if any clarifications on the PI are needed.