Pombiliti Injection, Powder, Lyophilized, For Solution
Product Images NDC 71904-200

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Pombiliti (NDC 71904-200). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amicus Therapeutics Us, Llc, 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 (Pombiliti 01)

This is a timeline diagram illustrating the fasting and medication schedule related to POMBILITI infusion. It shows starting fasting at hour 0, taking Opfolda at hour 2, beginning POMBILITI infusion at hour 3 with a typical infusion time of 4 hours, then stopping fasting at hour 4, and completing POMBILITI infusion by hour 7.*

FDA Label Image

Figure 2 (Pombiliti 02)

A line graph comparing the mean change from baseline in forced vital capacity (FVC) with standard error (± SE) over weeks from baseline for POMBILITI in combination with Opfolda versus a comparator. The graph shows data points at weeks 0, 12, 26, 38, and 52 with the number of subjects for each group displayed below the x-axis.*

FDA Label Image

Figure 3 (Pombiliti 03)

A line graph depicting the 6-minute walk distance (6MWD) mean change from baseline over 52 weeks, comparing POMBILITI in combination with Opfolda versus a comparator. The x-axis shows weeks from baseline (0, 12, 26, 38, 52), and the y-axis shows mean change with standard error bars. Data points show POMBILITI with higher improvements compared to the comparator at each time point, with numbers of subjects listed below the x-axis for each group.*

FDA Label Image

1 Count Carton Label (Pombiliti 04)

Label for POMBILITI ATGA injection, powder, lyophilized for solution, 105 mg per vial, cipaglucosidase alfa-atga by Amicus Therapeutics US, LLC. Includes dosage instructions, storage conditions (2°C to 8°C), single-dose vial warning, and trademarks for POMBILITI and OPFOLDA.*

FDA Label Image

1 Count Vial Label (Pombiliti 05)

POMBILITI 105 mg/vial (cipaglucosidase alfa-atga) injection, powder, lyophilized, for intravenous infusion. The carton includes dosage and storage instructions, inactive ingredients, a dosing timeline graphic, a barcode, and manufacturer information for Amicus Therapeutics US, LLC. The package contains 1 vial and features the POMBILITI logo and trademark.*

FDA Label Image

10 Count Multipack Label (Pombiliti 06)

POMBILITI 105 mg vial injection, lyophilized powder for solution, cipaglucosidase alfa-atga by Amicus Therapeutics US, LLC. The label displays product name, strength, route (intravenous infusion after reconstitution and dilution), packaging quantity of 10 vials, lot and expiration placeholders, storage instructions, and manufacturer details with barcode and QR code.*

FDA Label Image

25 Count Multipack Label (Pombiliti 07)

Packaging label for POMBILITI (cipaglucosidase alfa-atga) injection, powder, lyophilized, for solution, 105 mg per vial. The box design features red, green, and blue wave graphics and branding by Amicus Therapeutics US, LLC. The label states it is for intravenous infusion after reconstitution and dilution, with 25 vials per package. It includes dosage and storage instructions 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.