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UNII Code Assignment Request Email, March 11 2013 - Novoeight

 

From:                    Ananyeva, Natalya
Sent:                      Monday, March 11, 2013 4:02 PM
To:                         Pracht, Leigh
Subject:                 FW: UNII Code Assignment Request for STN 125466/0
Dear Leigh,
 
Below, I concur with Frank Switzer on the UNII code assignments.
 
Natalya
_____________________________________________
From: UNII_REQUEST
Sent: Friday, March 01, 2013 10:39 AM
To: Pracht, Leigh; CBER SRS
Cc: Callahan, Lawrence; Borodina, Yulia; Perkins, Vada
Subject: RE: UNII Code Assignment Request for STN 125466/0
 
Hi Leigh,
 
Here are the UNIIs
 

Ingredient
Preferred Substance Name
UNII
turoctocog alfa
TUROCTOCOG ALFA
969NZA3X9T
L-Histidine
HISTIDINE
4QD397987E
Sucrose
SUCROSE
C151H8M554
Polysorbate 80
POLYSORBATE 80
6OZP39ZG8H
Sodium Chloride
SODIUM CHLORIDE
451W47IQ8X
L-Methionine
METHIONINE
AE28F7PNPL
Calcium chloride dihydrate
CALCIUM CHLORIDE
M4I0D6VV5M
Water for injections
WATER
059QF0KO0R
----------(b)(4)----------
----------(b)(4)----------
------(b)(4)-----
----------(b)(4)----------
----------(b)(4)----------
------(b)(4)-----
------(b)(4)------
------(b)(4)------
------(b)(4)-----

 
Regards,
 
Frank
 
_______________________________
Frank L Switzer, PhD
Chemist, FDA Substance Registration System
WO 32 Room 4156
10903 New Hampshire Ave
Silver Spring, MD 20993
Office: 301.796.8506
Mobile: 240.401.5897
 
I concur on the above UNII code assignments.
 
Natalya
 Review Committee Chair
 
Natalya Ananyeva, Ph.D.
Senior Staff Fellow
FDA/CBER/OBRR/DH/LH
WOC-1, Office # 382N
1401 Rockville Pike
Rockville, MD 20852
Office: 301-827-6165
E-mail: Natalya.Ananyeva@fda.hhs.gov
 
_____________________________________________
From: Pracht, Leigh
Sent: Thursday, February 28, 2013 2:27 PM
To: CBER SRS
Subject: UNII Code Assignment Request for STN 125466/0
 
 
 << File: STN 125466.0   Annontated-draft-labeling.doc >>
Please provide a UNII Code assignment for:
 
 
STN: 125466/0
Applicant: NOVO NORDISK INC.
                                                  
Product:          Antihemophilic Factor (Recombinant), Plasma/Albumin Free [NovoEight]    
              
Short Summary: Original Biologics License Application (BLA) for NovoEight, Antihemophilic Factor (Recombinant), Plasma/Albumin-Free for the following proposed indications:
·                  Control and prevention of bleeding episodes in adults, adolescents and children with hemophilia A
·                  Perioperative management of patients with hemophilia A
·                  Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults, adolescents and
·                  children          
 
Table 1      Composition of turoctocog alfa drug product 250 IU, 500 IU, 1000 IU, 1500 IU,
2000 IU and 3000 IU
 

Name of components
Quantity per mL before lyophilisation
Quantity (nominal) per vial of lyophilised powder2
Quantity per mL in the withdrawal volume
Function
Reference to standards
Active substance
turoctocog alfa drug substance
250 IU1
250 IU
62.5 IU
Active ingredient
Novo Nordisk
A/S
turoctocog alfa drug substance
500 IU1
500 IU
125 IU
Active ingredient
Novo Nordisk
A/S
turoctocog alfa drug substance
1000 IU1
1000 IU
250 IU
Active ingredient
Novo Nordisk
A/S
turoctocog alfa drug substance
1500 IU1
1500 IU
375 IU
Active ingredient
Novo Nordisk
A/S
turoctocog alfa drug substance
2000 IU1
2000 IU
500 IU
Active ingredient
Novo Nordisk
A/S
turoctocog alfa drug substance
3000 IU1
3000 IU
750 IU
Active ingredient
Novo Nordisk
A/S
Excipients
L-Histidine
6 mg
6 mg
1.5 mg
--(b)(4)--
Ph Eur, USP, JP
Sucrose
12 mg
12 mg
3 mg
--(b)(4)--
Ph Eur, USP, JP
Polysorbate 80
0.4 mg
0.4 mg
0.1 mg
--(b)(4)--
Ph Eur, USP, JP
Sodium Chloride
36 mg
36 mg
18 mg3
--(b)(4)--
Ph Eur, USP, JP
L-Methionine
0.22 mg
0.22 mg
0.055 mg
--(b)(4)--
Ph Eur, USP, JP
Calciumchloride dihydrate
1.0 mg
1.0 mg
0.25 mg
--(b)(4)--
Ph Eur, USP, JP
Water for injections
To final volume
-
To final volume
Solvent
Ph Eur, USP, JP
-----(b)(4)------
(b)(4)
-
-
-------------(b)(4)--
--(b)(4)--
-----(b)(4)-----
(b)(4)
-
-
--(b)(4)------------------
--(b)(4)--
-----(b)(4)------
--(b)(4)--
-
+
-
-----(b)(4)-----
--(b)(4)--

1An overage of (b)(4) turoctocog alfa drug substance is added, see details in 3.2.P.2.3 Manufacturing Process
Development for Drug Product and3.2.P.2.2 Drug Product
2Nominal quantity per vial refers to the quantity per 4 mL
3The amount of sodium chloride originates from 9 mg from the formulation and 9 mg from the solvent 0.9% Sodium
Chloride Solution used for reconstitution
-----------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------
---------------------------------------------(b)(4)-----------------------------------------------------------------------
 
Thank you,
Leigh A. Pracht
Regulatory Project Manager
FDA/CBER/OBRR/DBA
WOC1; RM 572N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
Telephone: 301-827-6116
Fax: 301- 827-2857
Leigh.Pracht@fda.hhs.gov