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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review Memo - Isoplate Solution

DEPARTMENT OF HEALTH & HUMAN SERVICES

 U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality

To:                  File: NDA BN090067 Isoplate Solution 
                        
From:              Nawab A Siddiqui, MRB II, DMPQ, OCBQ, HFM-676

 

Through:         Chiang Syin, Ph.D., Chief, MRB II, DMPQ, OCBQ, HFM-676
           
Subject:          Review Memo NDA: [B. Braun Medical Inc.]: Manufacturing Site: Irvine, Ca.               
 

Action Due:    April 14, 2011
 


Action Recommended
Approval.
           
Summary
B. Braun Medical Inc. (B. Braun) submitted this original new drug application (NDA), for the drug product, Isoplate Solution in the 500mL EXCEL® container. This product is identical to the already approved Isolyte S, pH 7.4 multi electrolyte injection manufactured by B. Braun. The only difference between the Isoplate product and the approved Isolyte S, pH 7.4 product is the indication. The proposed indication for Isoplate Solution is a platelet additive solution for the storage of leukoreduced hyperconcentrated apheresis platelets collected in CaridianBCT’s Trima Accel® System under standard blood banking conditions. This change in the indication will be reviewed by the product office.

Submission Content
This NDA is an electronic submission, consisting of a cover letter, FDA form 356h and Establishment Description (FEIBA Study Report: VN-PV010 09-02-SR.02).

Review Narrative
Isoplate Solution (Multi-Electrolyte Injection) is identical in formulation, packaging, sterilization, and manufacturing as B. Braun’s already approved Isolyte S, pH 7.4 (Multi-Electrolyte Injection), ANDA 019696.

Isolyte S, pH 7.4 Multi-Electrolyte Solution (Isolyte S) is a FDA approved sterile, nonpyrogenic intravenous injection packaged in B. Braun’s EXCEL® Container. Isolyte S is approved, as of September 29, 1989 (ANDA 19-696), for the following indication: For use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.

The only difference between the Isoplate product and the approved Isolyte S, pH 7.4 (Multi-Electrolyte Injection) product is the indication. The proposed indication for Isoplate Solution is a platelet additive solution for the storage of leukoreduced hyperconcentrated apheresis platelets collected in CaridianBCT’s Trima Accel® System under standard blood banking conditions.

Isoplate Solution is sterile, nonpyrogenic and packaged in the B. Braun’s EXCEL® container. The finished drug product consists of a sterile multi-electrolyte solution, intended for intravenous administration.

The active ingredients are as follows: Sodium Chloride USP; Sodium Gluconate USP; Sodium Acetate Trihydrate USP; Potassium Chloride USP; Magnesium Chloride Hexahydrate USP; Dibasic Sodium Phosphate Heptahydrate USP; Monobasic Potassium Phosphate NF The inactive ingredients are as follows: Water for Injection USP; Glacial Acetic Acid USP; Sodium Hydroxide NF.

Facility Information
Isoplate Solution is manufactured at the following site.
B. Braun Medical Inc.
2525 McGaw Avenue
Irvine, CA 92614
FEI # 2021236

B. Braun stated that there is no change in formulation, packaging, sterilization, and manufacturing process of this product. The only change is the indication for the product. The proposed indication for Isoplate Solution is a platelet additive solution for the storage of leukoreduced hyperconcentrated apheresis platelets collected in CaridianBCT’s Trima Accel® System under standard blood banking conditions. The change in the indication will be reviewed by the product office.