ANDA 202111, held by Hospira. Pemetrexed Disodium.
As of Nov 15, 2026, ANDA 202111 (Pemetrexed Disodium), held by Hospira, was first approved by FDA on May 25, 2022, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 25, 2022 | Original application | Approved | None posted |
| Pemetrexed DisodiumEQ 100MG BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Discontinued |
| Pemetrexed DisodiumEQ 500MG BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Discontinued |
| Pemetrexed DisodiumEQ 1GM BASE/VIAL · powder;intravenous | Pemetrexed Disodium | Discontinued |
| Aug 29, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 25, 2022 | Original application | Approved | None posted |
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
