Source: FDA, National Drug Code (US) Revision Year: 2026
GENGLYCOS (pariglasgene brecaparvovec-opnr) is an adeno-associated viral vector-based gene therapy product. GENGLYCOS is a non-replicating, recombinant adeno-associated serotype 8 (AAV8) based vector containing a codon-optimized, wild-type human G6PC gene under the control of native G6PC promoter and enhancer elements. GENGLYCOS is produced in human embryonic kidney cells by recombinant DNA technology.
GENGLYCOS is a sterile, clear to translucent suspension for intravenous infusion after dilution. Each vial of GENGLYCOS contains an extractable volume of 2 mL of pariglasgene brecaparvovec-opnr at a concentration of 3.0 x 1013 genome copies per mL (gc/ml) and the following excipients: magnesium chloride (0.2 mg/mL) poloxamer 188 (0.1 mg/mL), sodium chloride (11.7 mg/mL), and tris (2.4 mg/mL). The pH of GENGLYCOS is 7.5-8.5.
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GENGLYCOS is supplied as a clear to translucent suspension for intravenous infusion at a concentration of 3.0 x 1013 genome copies/mL (gc/ml). Each vial of GENGLYCOS contains 2 mL of extractable volume. GENGLYCOS is provided in a kit containing 3 to 15 single-dose vials, with each kit constituting a dosage unit based on the patient's body weight [see How Supplied/Storage and Handling (16.1)]. |
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GENGLYCOS is supplied as a clear to translucent suspension for intravenous infusion. GENGLYCOS contains 3.0 × 1013 genome copies per mL. GENGLYCOS is shipped frozen ≤ -60ºC (-76ºF) in 8 mL vials, with an extractable volume of 2 mL. GENGLYCOS is provided as a kit to meet the dosing requirements for each patient. Each kit contains a specified number of GENGLYCOS vials (NDC 69794-332-01), with a minimum of 3 vials and a maximum of 15 vials. The total number of vials in each kit corresponds to the dosing requirement for the individual patient, based on the patient's body weight [see Dosage and Administration (2.2)]. Kit sizes and National Drug Codes (NDC) are provided in Table 6. Table 6. GENGLYCOS Kits:
Manufactured by: Ultragenyx Pharmaceutical Inc., Novato, CA 94949 |
| Drug | Countries | |
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| GENGLYCOS | United States |
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