ANDA 206983, held by X-Gen Pharms Inc. Pentamidine Isethionate.
As of Nov 15, 2026, ANDA 206983 (Pentamidine Isethionate), held by X-Gen Pharms Inc, was first approved by FDA on Jan 20, 2023, 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 |
|---|---|---|---|
| Jan 20, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pentamidine Isethionate300MG/VIAL · for solution;inhalation | Pentamidine Isethionate | Rx |
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
