ANDA 206667, held by Pai Holdings. Pentamidine Isethionate.
As of Nov 15, 2026, ANDA 206667 (Pentamidine Isethionate), held by Pai Holdings, was first approved by FDA on Apr 24, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Pentamidine Isethionate is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of PJP ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3. These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pentamidine Isethionate300MG/VIAL · for solution;inhalation | Pentamidine Isethionate | Rx |
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