PULMOTECH MAA
Pulmotech MAA is a radioactive diagnostic agent used in medical imaging procedures for both adult and pediatric patients. After radiolabeling with technetium-99m, the agent is utilized as an adjunct in lung scintigraphy to evaluate pulmonary perfusion. In adult populations, it is also indicated for use in peritoneovenous shunt scintigraphy to assist in the assessment of shunt patency.
How PULMOTECH MAA Works
Following intravenous injection, more than 90 percent of the technetium Tc 99m albumin aggregated particles are trapped within the arterioles and capillaries of the lungs. For shunt evaluation, the agent is administered intraperitoneally where it mixes with peritoneal fluid. The rate at which the agent clears from the peritoneal cavity and enters systemic circulation indicates whether the peritoneovenous shunt is patent or blocked.
Details
- Status
- Prescription
- First Approved
- 2020-03-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PULMOTECH MAA Approval History
What PULMOTECH MAA Treats
2 indicationsPULMOTECH MAA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lung scintigraphy for pulmonary perfusion evaluation
- Peritoneovenous shunt scintigraphy for patency evaluation
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PULMOTECH MAA FDA Label Details
ProIndications & Usage
FDA Label (PDF)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. PULMOTECH MAA, after radiolabeling with technetium-99m is a radioactive diagnostic agent 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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.