porcine (pig) insulin
Status: no longer manufactured; phased out
Organizations involved:
Novo Nordisk A/S – R&D; Tech.; Parent co
Novo Nordisk Pharmaceuticals, Inc. – Manuf.; USA mark.
Cross ref: See the Insulin Products entry (#559).
Description: Insulin, Pork refers to formulations of insulin obtained from porcine (pig) pancreas. Pork insulin is composed of 21-amino acid A chain linked via cysteine at residue 7 to cysteine at residue 7 of 22-amino acid B chain, with a molecular weight of 5,777.66 Daltons (~5.8 kDa). Novo formerly marketed various formulations of pork insulin including Insulin, Pork (Regular); Insulin, Pork, Purified, Isophane Suspension; and Insulin, Pork, Purified, Zinc Suspension.
Nomenclature: Insulin, Pork/Novo [BIO]; Purified Pork Insulin R [TR for regular uncomplexed]; Purified Pork N [TR for Isophane NPH suspension]; Purified Pork L [TR for zinc formulation]; Insulatard NPH [TR for Isophane suspension]; Insulin, Pork (Regular) [FDA]; Insulin, Pork, NPH Purified, Isophane Suspension [FDA]; Insulin, Pork, Purified, Isophane Suspension [FDA]; Insulin, Pork, Purified, Zinc Suspension [FDA]; Purified Pork Insulin Injection USP [USAN for regular uncomplexed insulin]; Insulin USP [USAN for regular]; Insulin, Neutral [USAN for regular unbuffered pork insulin]; Insulin, Neutral Injection [INN BAN]; Purified Pork Insulin Isophane Suspension USP [USAN USP]; Insulin [Suspension], Isophane [USAN]; Insulin [Suspension], Isophane Injection [INN]; Purified Pork Insulin Zinc Suspension USP [USAN USP]; Compound Insulin Zinc Suspension [INN]; Insulin Zinc [CAS USAN BAN for zinc complex]; Insulin Zinc Injection [JAN]; Insulin Zinc Purified Porcine (Suspension) [JAN]; Insulin (pig) [CAS]; Insulin (ox), 8A-L-threonine-10A-L-isoleucine- [CAS]; 12584-58-6 [CAS RN for regular uncomplexed pork insulin]; 9004-14-2 [CAS RN for Insulin, Neutral]; 8049-62-5 [CAS RN for Insulin [Suspension], Isophane]; pig insulin [SY]; porcine insulin [SY]
Companies: Insulin, Pork products were manufactured by Novo Nordisk Pharmaceuticals Industries, Inc. (Clayton, NC), and/or at parent company facilities in Denmark. The products were originally developed by the Nordisk Insulinlaboratorium and Novo Industri A/S, which merged to form Novo Nordisk.
FDA class: Drug NDA
Approvals: Date = unknown; See the History section of the Insulin Products entry (#559).
Indications: for treatment of diabetes mellitus [unofficial; product insert/labeling not available]
Status: Novo Nordisk no longer manufactures or markets porcine insulin in the U.S. The company now concentrates on recombinant insulin and other products.
Market: The Average Wholesale Price (AWP) in 2002 for Novolin R, Novolin L and Novoin NPH, each in 100 U, 10 mL vials, was $46.13.
Companies involvement:
Full monograph
633 Insulin, Pork/Novo
Nomenclature:
Insulin, Pork/Novo [BIO]
Purified Pork Insulin R [TR for regular uncomplexed]
Purified Pork N [TR for Isophane NPH suspension]
Purified Pork L [TR for zinc formulation]
Insulatard NPH [TR for Isophane suspension]
Insulin, Pork (Regular) [FDA]
Insulin, Pork, NPH Purified, Isophane Suspension [FDA]
Insulin, Pork, Purified, Isophane Suspension [FDA]
Insulin, Pork, Purified, Zinc Suspension [FDA]
Insulin USP [USAN for regular]
Insulin, Neutral [USAN for regular unbuffered pork insulin]
Purified Pork Insulin Injection USP [USAN for regular uncomplexed insulin]
Insulin, Neutral Injection [INN BAN]
Insulin [Suspension], Isophane [USAN ]
Insulin [Suspension], Isophane Injection [INN]
Purified Pork Insulin Isophane Suspension USP [USAN USP]
Purified Pork Insulin Zinc Suspension USP [USAN USP]
Compound Insulin Zinc Suspension [INN for zinc suspension]
Insulin Zinc [CAS USAN BAN for zinc complex]
Insulin Zinc Injection [JAN]
Insulin Zinc Purified Porcine (Suspension) [JAN]
Insulin (ox), 8A-L-threonine-10A-L-isoleucine- [CAS]
Insulin (pig) [CAS]
12584-58-6 [CAS RN for regular uncomplexed pork insulin]
9004-14-2 [CAS RN for Insulin, Neutral]
8049-62-5 [CAS RN for Insulin [Suspension], Isophane]
pig insulin [SY]
porcine insulin [SY]
C256H381N65O76S6 [MF for regular]
FDA Class: Drug NDA
Year of approval (FDA) = 1921
Date of 1st FDA approval = 19210000
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
hormones
insulin, recombinant human
porcine pancreas
protamine
zinc
apheresis (hemapheresis)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU003 EU application withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
Copyright© 2020, Biotechnology Information Institute