NDA 205555, held by Novatech SA. Talc.
As of Nov 13, 2026, NDA 205555 (Steritalc), held by Novatech SA, was first approved by FDA on May 1, 2017, with 1 approved supplement and 0 published complete response letters.
1.INDICATIONS AND USAGE 1.INDICATIONS AND USAGE 1.1 Malignant Pleural Effusion STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. 1.2 Pneumothorax STERITALC is indicated in adults to decrease the recurrence of pneumothorax. ___________ INDICATIONS AND USAGE__ __________ STERITALC is a sclerosing agent indicated: To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. In adults to decrease the recurrence of pneumothorax.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Jun 10, 2025 | Supplement 5Labeling · Standard review | Approved | |
| May 1, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
