Skysona Suspension
Product Images NDC 73554-2111

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Skysona (NDC 73554-2111). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Genetix Biotherapeutics Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Skysona 01)

A survival probability chart comparing Skysona (elivaldogene autotemcel) treatment versus natural history over a 24-month period. The Y-axis shows survival probability in percent, and the X-axis shows months from initial NFS>0. The chart includes subject numbers at risk for both Skysona and natural history groups at various time points.*

FDA Label Image

Figure 2 (Skysona 02)

A survival probability curve chart depicting survival probability (%) over months from treatment (0 to 24). The chart compares three groups: SKYSONA, HSCT Mismatched, and HSCT Matched. It includes a legend and a table listing the number of subjects at risk at specific time points for each group.*

FDA Label Image

Principal Display Panel (20 mL Bag Patient Identifier Label)

Label for Skysona (elivaldogene autotemcel) suspension for intravenous infusion. The label includes dose volume of 20 mL with specified cell concentration, patient identifier placeholders, lot and expiry info, and a logo for bluebird bio. It also notes the U.S. license number and label part number.*

FDA Label Image

Principal Display Panel (20 mL Bag Label)

Label for Skysona (elivaldogene autotemcel) suspension for intravenous infusion. The label indicates a 20 mL vial containing 4 to 30 million cells per mL, specifying CD34+ cells concentration. It is intended for autologous use only and is prescription-only. The label includes manufacturing information for bluebird bio, Inc., Somerville, MA. A barcode and usage warnings are also present.*

FDA Label Image

Principal Display Panel (20 mL Bag Cassette Label)

Label for Skysona (elivaldogene autotemcel) suspension for IV infusion containing 20 mL with 4 to 30 million cells/mL. The label includes usage instructions emphasizing autologous intravenous use, storage conditions in vapor phase liquid nitrogen, and warnings against irradiation and use of blood filters or infusion pumps. It notes the product contains genetically modified cells and no preservatives. Manufacturer is bluebird bio, Inc., Somerville, MA, with contact information and a barcode.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.