BLA 210089, held by Cis Bio Intl. Technetium Tc99m Albumin Aggregated.
As of Nov 13, 2026, BLA 210089 (Pulmotech Maa), held by Cis Bio Intl, was first approved by FDA on Mar 20, 2020, with 1 approved supplement and 0 published complete response letters.
PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for: Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pulmotech Maa2MG · injectable;injection | Technetium Tc99m Albumin Aggregated | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Mar 20, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
