N O T I C E S O F C O M P L I A N C E BIOLOGIC PRODUCTS FOR HUMAN USE January - December 1992 ----------------------------------------------------------------- Brand Name: Abbokinase Source: Abbott Active Ingredient: Urokinase Comments: Revised labelling, revised product monograph Date: 92-07-30 ----------------------------------------------------------------- Brand Name: Abbokinase Source: Abbott Active Ingredient: Urokinase Comments: New strength Date: 92-07-31 ----------------------------------------------------------------- Brand Name: Act-HIB Source: Connaught Active Ingredient: Haemophilus b Conjugate Vaccine (Tetanus Protein-Conjugate) Comments: Alternate method of administration Date: 92-03-19 ----------------------------------------------------------------- Brand Name: Act-HIB Source: Connaught Active Ingredient: Haemophilus b Conjugate Vaccine (Tetanus Protein-Conjugate) Comments: PWS (10 mcg purified capsular polysaccharide and 20 mcg tetanus protein per dose [0.5 mL]) IM Date: 92-03-19 ----------------------------------------------------------------- Brand Name: ActivaseR rt-PA Source: Genentech Active Ingredient: Alteplase Comments: Alternate manufacturing site Date: 92-06-11 ----------------------------------------------------------------- Brand Name: Arvin Source: Knoll Active Ingredient: Ancrod Comments: Revised product monograph Date: 92-10-19 ----------------------------------------------------------------- Brand Name: Botox Source: Allergan Active Ingredient: Clostridium botulinum toxin type A Comments: PWS (100 u/vial) IM Date: 92-05-05 ----------------------------------------------------------------- Brand Name: Digibind Source: Burroughs Wellcome Active Ingredient: Digoxin immune Fab (Ovine) Comments: Alternate manufacturing site Date: 92-07-31 ----------------------------------------------------------------- Brand Name: DPT Adsorbed Source: Connaught Active Ingredient: Diphtheria and tetanus toxoids and pertussis vaccine adsorbed Comments: Change in manufacturing Date: 92-09-30 ----------------------------------------------------------------- Brand Name: DPT-Hib Source: Connaught Active Ingredient: Diphtheria and Tetanus Toxoids Adsorbed and Pertussis Vaccine combined with Haemophilus b Conjugate Vaccine (Diphtheria Toxoid - Conjugate) Comments: INJ SUS (0.5 mL dose) IM Date: 92-07-29 ----------------------------------------------------------------- Brand Name: Energix-B Source: SmithKline Beecham Active Ingredient: Hepatitis B vaccine, recombinant Comments: Change in manufacturer, revised labelling Date: 92-05-05 ----------------------------------------------------------------- Brand Name: Engerix B Source: SmithKline Active Ingredient: Hepatitis B vaccine, recombinant Comments: New dose, new package size Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Eprex Sterile Solution Source: Ortho Pharmaceutical Active Ingredient: Recombinant human erythropoietin Comments: New strength Date: 92-02-27 ----------------------------------------------------------------- Brand Name: Eprex Sterile Solution Source: Ortho Pharmaceutical Active Ingredient: Recombinant human erythropoietin Comments: Alternate source of active ingredient, alternate manufacturing site Date: 92-02-28 ----------------------------------------------------------------- Brand Name: Eprex Sterile Solution Source: Ortho McNeil Active Ingredient: Recombinant human erythropoietin Comments: Change in manufacturer's name Date: 92-08-14 ----------------------------------------------------------------- Brand Name: Hemofil M Source: Baxter Active Ingredient: Antihemophilic Factor (Human) Comments: New expiration date, change in manufacturing Date: 92-04-24 ----------------------------------------------------------------- Brand Name: HibTiter Source: Lederle-Cyanamid Active Ingredient: Haemophilus b Conjugate Vaccine (Diptheria CRM197 Protein Conjugate) Comments: Alternate manufacturing site Date: 92-02-04 ----------------------------------------------------------------- Brand Name: HibTiter Source: Lederle-Cyanamid Active Ingredient: Haemophilus b Conjugate Vaccine (Diptheria CRM197 Protein Conjugate) Comments: Change in manufacturing Date: 92-10-06 ----------------------------------------------------------------- Brand Name: HibTiter Source: Lederle-Cyanamid Active Ingredient: Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate) Comments: Change in manufacturing Date: 92-12-11 ----------------------------------------------------------------- Brand Name: Honey Bee Venom Source: ALK Laboratories Active Ingredient: Apis mellifera venom extract Comments: PWS (120 ug vial, 1.1 mg vial (100 ug/mL)) IND, SC Date: 92-02-28 ----------------------------------------------------------------- Brand Name: Humatrope Source: Eli Lilly Active Ingredient: Somatropin Comments: New presentation Date: 92-03-05 ----------------------------------------------------------------- Brand Name: Humatrope Source: Eli Lilly Active Ingredient: Somatropin Comments: Change in manufacturing Date: 92-10-06 ----------------------------------------------------------------- Brand Name: Humegon Source: Organon Active Ingredient: Human gonadotropin Comments: INJ PWS (75 IU FSH/75 IU/standardized with hCG) IM Date: 92-07-31 ----------------------------------------------------------------- Brand Name: Humulin Source: Eli Lilly Active Ingredient: Insulin human biosynthetic Comments: Change in manufacturing Date: 92-11-18 ----------------------------------------------------------------- Brand Name: Humulin 10/90, 20/80, 40/60, 50/50 Cartrige and Vial Source: Eli Lilly Active Ingredient: Insulin injection, insulin isophane, human biosynthetic Comments: INJ SOL (100 U/ml (10/90, 20/80, 40/60, 50/50)) SC Date: 92-10-06 ----------------------------------------------------------------- Brand Name: Humulin R, N and 30/70 Cartridges Source: Eli Lilly Active Ingredient: Insulin human biosynthetic Comments: New dosage form Date: 92-01-17 ----------------------------------------------------------------- Brand Name: Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV Source: Connaught Active Ingredient: Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV Comments: Change in manufacturing Date: 92-05-25 ----------------------------------------------------------------- Brand Name: Inactivated Poliomyelitis Vaccine (Diploid Cell Origin)-IPV Source: Connaught Active Ingredient: Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) Comments: Change in manufacturing Date: 92-11-30 ----------------------------------------------------------------- Brand Name: Initard Nordisk Source: Novo Nordisk Active Ingredient: Insulin injection (pork) 50% and insulin isophane (pork) 50% Comments: Change in manufacturer's name, revised labelling Date: 92-06-04 ----------------------------------------------------------------- Brand Name: Insulatard Human NPH Source: Novo Nordisk Active Ingredient: Insulin isophane human semi- synthetic Comments: Change in packaging Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Intron A Source: Schering Active Ingredient: Interferon alfa-2b Comments: New indication Date: 92-04-10 ----------------------------------------------------------------- Brand Name: Iveegam Immuno Source: Osterreichishes Institut fur Haemoderivate Ges. m.b.H. Active Ingredient: Immune globulin (Human) Comments: Change in product name Date: 92-01-03 ----------------------------------------------------------------- Brand Name: Lysatec rt-PA Source: Boehringer Ingelheim Active Ingredient: Alteplase Comments: PWS (50 mg) IV Date: 92-10-16 ----------------------------------------------------------------- Brand Name: Marogen Sterile Powder Source: Upjohn Active Ingredient: Epoetin beta Comments: PWS (2000 units) IV Date: 92-10-23 ----------------------------------------------------------------- Brand Name: Mencevax AC Source: SmithKline Beecham Active Ingredient: Meningococcal Polysaccharide Vaccine, Groups A and C Comments: PWS (1-, 10-, 50-Dose Vials) SC Date: 92-01-17 ----------------------------------------------------------------- Brand Name: Meningococcal Polysaccharide Vaccine, Groups A & C Source: Connaught Active Ingredient: Meningococcal Polysaccharide Vaccine, Groups A & C Comments: PWS (1-, 10-, 50-dose vials) SC Date: 92-01-23 ----------------------------------------------------------------- Brand Name: Menomune - A/C/Y/W-135 Source: Connaught Active Ingredient: Meningococcal Polysaccharide Vaccine, Groups A,C,Y and W-135 Combined Comments: New package size Date: 92-01-14 ----------------------------------------------------------------- Brand Name: Mixed Vespid Venom Protein Source: ALK Laboratories Active Ingredient: Venom Protein (Yellow Jacket, Yellow Hornet, White Faced Hornet) Comments: PWS (360 ug vial, 3.3 mg vial (300 ug/mL)) IND, SC Date: 92-02-28 ----------------------------------------------------------------- Brand Name: Mixtard 30/70 Human Source: Novo Nordisk Active Ingredient: Insulin injectable (30%) and insulin isophane (70%) human semi- synthetic Comments: Change in packaging Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Mixtard Nordisk Source: Novo Nordisk Active Ingredient: Insulin injection (pork) 30% and insulin isophane (pork) 70% Comments: Change in manufacturer's name, revised labelling Date: 92-06-04 ----------------------------------------------------------------- Brand Name: Neupogen Source: Amgen Active Ingredient: Filgrastim (recombinant methionyl human Granulocyte Colony Stimulating Factor) Comments: Sol (Sterile) (300 ug/mL) SC, IV Date: 92-02-11 ----------------------------------------------------------------- Brand Name: Nordisk Insulins (insulin human semi- synthetic) Source: Novo Nordisk Active Ingredient: Insulin human semi-synthtic Comments: Change in manufacturer's name, revised labelling Date: 92-06-05 ----------------------------------------------------------------- Brand Name: Novolin Source: Novo Nordisk Active Ingredient: Insulin human semi-synthetic Comments: Change in manufacturer's name, revised labelling Date: 92-06-04 ----------------------------------------------------------------- Brand Name: Orthoclone OKT*3 Source: Ortho-McNeil Active Ingredient: Muromonab-CD3 Comments: LIQ (1 mg/mL) IV Date: 92-12-23 ----------------------------------------------------------------- Brand Name: PedvaxHIB Source: Merck Frosst Active Ingredient: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Comments: New expiration date, change in manufacturing Date: 92-08-21 ----------------------------------------------------------------- Brand Name: Pergonal R 75 Source: Serono Active Ingredient: Menotropins Comments: New expiration date Date: 92-06-30 ----------------------------------------------------------------- Brand Name: Poliovirus Vaccine Live Oral Trivalent Diploid Cell Origin Source: Connaught Active Ingredient: Poliovirus Vaccine Live Oral Trivalent - DCO Comments: Change in formulation Date: 92-05-19 ----------------------------------------------------------------- Brand Name: Poliovirus Vaccine Live Oral Trivalent Monkey Kidney Source: Connaught Active Ingredient: Poliovirus Vaccine Live Oral Trivalent - MK Comments: Change in formulation Date: 92-05-19 ----------------------------------------------------------------- Brand Name: Poliovirus Vaccine Live Oral Trivalent- DCO Source: Connaught Active Ingredient: Poliovirus Vaccine Live Oral Trivalent-DCO Comments: New packaging, dosage Date: 92-01-28 ----------------------------------------------------------------- Brand Name: Poliovirus Vaccine Live Oral Trivalent- Diploid Cell Origin Source: Connaught Active Ingredient: Poliovirus Vaccine Live Oral Trivalent-DCO Comments: Change in packaging Date: 92-03-25 ----------------------------------------------------------------- Brand Name: Poliovirus Vaccine Live Oral Trivalent- Monkey Kidney Source: Connaught Active Ingredient: Poliovirus Vaccine Live Oral Trivalent-MK Comments: New packaging, new dosage Date: 92-02-11 ----------------------------------------------------------------- Brand Name: Poliovirus Vaccine Live Oral Trivalent- Monkey Kidney Source: Connaught Active Ingredient: Poliovirus Vaccine Live Oral Trivalent-MK Comments: Change in packaging Date: 92-03-25 ----------------------------------------------------------------- Brand Name: Protropin Source: Genentech Active Ingredient: Somatrem Comments: Alternate manufacturing site, new strength Date: 92-06-11 ----------------------------------------------------------------- Brand Name: Recombinante Source: Baxter Active Ingredient: Antihemophilic factor, recombinant Comments: INJ SOL (250, 500, 1000 I.U./vial) IV Date: 92-12-10 ----------------------------------------------------------------- Brand Name: Recombivax HB Source: Merck Frosst Active Ingredient: Hepatitis B Vaccine, Recombinant Comments: New dosage regimen Date: 92-01-23 ----------------------------------------------------------------- Brand Name: Roferon A Source: Hoffmann La-Roche Active Ingredient: Interferon alfa-2a Comments: Change in manufacturing Date: 92-03-31 ----------------------------------------------------------------- Brand Name: Roferon A Source: Hoffmann La-Roche Active Ingredient: Interferon alfa-2a Comments: New indication Date: 92-03-31 ----------------------------------------------------------------- Brand Name: Roferon A Source: Hoffmann-La Roche Active Ingredient: Interferon alfa-2a Comments: New indication Date: 92-08-21 ----------------------------------------------------------------- Brand Name: Roferon-A Solution Source: Hoffmann-LaRoche Active Ingredient: Interferon alfa-2a Comments: New expiration date Date: 92-07-20 ----------------------------------------------------------------- Brand Name: Tisseel Kit VH [Two Component Fibrin Sealant (Human), Vapor Heated] Source: Osterreichisches Institut Active Ingredient: Tisseel Sealer Protein Concentrate (Human), Aprotinin (bovine), Thrombin (bovine), Calcium Chloride Comments: Kit Topical Date: 92-03-03 ----------------------------------------------------------------- Brand Name: Velosulin Source: Novo Nordisk Active Ingredient: Insulin injection (pork) Comments: Change in manufacturer's name, revised labelling Date: 92-06-04 ----------------------------------------------------------------- Brand Name: Velosulin Human Source: Novo Nordisk Active Ingredient: Insulin injection human semi- synthetic Comments: Change in packaging Date: 92-09-11 ----------------------------------------------------------------- Brand Name: Vivotif Berna Vaccine Source: Swiss Serum and Vaccine Institute Active Ingredient: Typhoid Vaccine Live, Oral, Attenuated Ty 21a Comments: CAP (2-6 billion CFU / per capsule) ORAL Date: 92-08-21 ----------------------------------------------------------------- Brand Name: Wasp Venom Protein Source: ALK Laboratories Active Ingredient: Polistes spp venom protein extract Comments: PWS (120 ug vial, 1.1 mg vial (100 ug/mL)) IND, SC Date: 92-02-28 ----------------------------------------------------------------- Brand Name: Wellferon Source: Burroughs Wellcome Active Ingredient: Interferon alfa-n1 (ms) Comments: Inj Sol Liq (3, 10 mega units/mL) IM or SC Date: 92-03-26 ----------------------------------------------------------------- Brand Name: White Faced Hornet Venom Protein Source: ALK Laboratories Active Ingredient: Dolichovespula maculata venom protein extract Comments: INJ lyophilized (PWS) (120 ug vial, 1.1 mg vial (100 ug/mL)) IND, Subcutaneous Date: 92-02-28 ----------------------------------------------------------------- Brand Name: Yellow Hornet Venom Protein Source: ALK Laboratories Active Ingredient: Dolichovespula arenaria venom protein extract Comments: PWS (120 ug vial, 1.1 mg vial (100 ug/mL)) IND, SC Date: 92-02-28 ----------------------------------------------------------------- Brand Name: Yellow Jacket Venom Protein Source: ALK Laboratories Active Ingredient: Vespula spp venom protein extract Comments: PWS (120 ug vial, 1.1 mg vial (100 ug/mL)) IND, SC Date: 92-02-28 -----------------------------------------------------------------