Table 3.
FDA-approved rhGH products for subcutaneous administration.
| Company | Brand | Dosage Form | Buffer | pH | Preservative | Concentration | Other Excipients |
|---|---|---|---|---|---|---|---|
| Pfizer | Genotropin® | Powder | Phosphate | 6.7 | m-Cresol | 5 and 12 mg/ml | Glycine Mannitol Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous |
| Genotropin® MiniQuick | Powder | Phosphate | 6.7 | Preservative-free | 0.2, 0.4, 0.6, 0.8, 1, 1.2, 1.4, 1.6, 1.8 and 2 mg/ml | Glycine Mannitol Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous |
|
| Novo Nordisk | Sograya®
(Sustained-release) |
Solution | Histidine | 6.8 | Phenol | 6.7 mg/ml | Mannitol Phenol Poloxamer 188 |
| Norditropin® | Solution | Histidine | Phenol | 5 mg/1.5 ml, 10 mg/1.5 ml, 15 mg/1.5 ml and 30 mg/1.5 ml | Poloxamer 188 Mannitol |
||
| Genentech | Nutropin® | Powder | Phosphate | 7.4 | Benzyl alcohol | 5 and 10 mg/ml | Glycine Mannitol Sodium phosphate monobasic Sodium phosphate dibasic |
| Nutropin AQ® | Solution | Citrate | 6 | Phenol | 5, 10 or 20 mg/ml | Polysorbate 20 NaCl |
|
| Nutropin Depot®
(long-acting) |
Powder | Acetate and carbonate | 5.8-7.2 | Preservative-free | 13.5, 18 and 22.5 mg/3ml | Zinc acetate Zinc carbonate PLG Polysorbate 20 Carboxymethylcellulose sodium salt NaCl |
|
| Somatrem® (Protropin®) | Powder | Phosphate | 7.4 | Benzyl alcohol | 5 mg/ml | Mannitol Sodium phosphate |
|
| Sandoz | Omnitrope® | Solution | Phosphate | 7 | Benzyl alcohol | 5 mg/1.5 ml cartridge | Disodium hydrogen phosphate heptahydrate Sodium dihydrogen phosphate dihydrate Poloxamer 188 Mannitol |
| Phenol | 10 mg/1.5 ml cartridge | Disodium hydrogen phosphate heptahydrate Sodium dihydrogen phosphate dihydrate Poloxamer 188 Glycine |
|||||
| Powder | Phosphate | 7 | Benzyl alcohol | 5.8 mg/vial | Disodium hydrogen phosphate heptahydrate Sodium dihydrogen phosphate dihydrate Glycine |
||
| EMD Serono | Saizen® | Powder | Citrate | 6.5-8.5 | Benzyl alcohol | 5 mg/vial | Sucrose O-phosphoric acid |
| 8.8 mg/vial | Sucrose O-phosphoric acid Glycine |
||||||
| Serostim® | Powder | 6.5-8.5 | Preservative-free | 5 mg single-use vials | Sucrose Phosphoric acid |
||
| 7.4-8.5 | Preservative-free | 6 mg single-use vials | |||||
| 7.4-8.5 | Benzyl alcohol | 4 mg multiple-use vial | |||||
| Easyclick® | Powder | Citrate | 6.5-8.5 | m-Cresol | 5.83 mg/ml | Sucrose Phosphoric acid |
|
| Zorbtive® | Powder | Phosphate | 7.4-8.5 | Benzyl alcohol | 8.8 mg/vial | Sucrose Phosphoric acid Sodium phosphate dibasic Glycine |
|
| Biotechnology General | Biotropin® | Powder | Benzyl alcohol | 3.33 and 4 mg/vial | NaCl | ||
| Citrate | 5.5-6.5 | Phenol | 5.83 and 8 mg/ml cartridges | Sucrose Poloxamer 188 Citric acid |
|||
| Ferring | Zomacton® | Powder | 7-9 | Benzyl alcohol | 5 mg vial | Mannitol NaCl |
|
| Phosphate | m-Cresol | 10 mg vial | Mannitol Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dehydrate |
||||
| Biopartners GmbH | Valtropin® | Powder | Phosphate | 7.5 | m-Cresol | 3.33 mg/ml | Glycine Mannitol Monobasic sodium phosphate Dibasic sodium phosphate |
| Cangene | Accretropin® | Solution | Phosphate | 6 | Phenol | 5 mg/ml | Poloxamer 188 Sodium phosphate NaCl |
| Eli Lilly | Humatrope® | Powder | Phosphate | 7.5 | m-Cresol | 5 mg/vial 6, 12 and 24 mg cartridges |
Mannitol Glycine Dibasic sodium phosphate Glycerin |
| TEVA | TEV-Tropin® | Powder | Phosphate | 7-9 | Benzyl alcohol | 5 mg/vial | Mannitol NaCl |
| m-Cresol | 10 mg/vial | Mannitol Sodium dihydrogen phosphate |
|||||
| ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S | SKYTROFA®
(long-acting) |
Powder | Tromethamine | 5 | Preservative-free | 3, 3.6, 4.3, 5.2, 6.3, 7.6, 9.1, 11 and 13.3 mg/vial | Succinic acid Trehalose dihydrate |