Treats primary systemic carnitine deficiency. ANDA 211676, held by Novitium Pharma. Levocarnitine.
As of Nov 13, 2026, ANDA 211676 (Levocarnitine, Levocarnitine Sf), held by Novitium Pharma, was first approved by FDA on Aug 14, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levocarnitine1GM/10ML · solution;oral | Levocarnitine | Rx |
| Levocarnitine Sf1GM/10ML · solution;oral | Levocarnitine | 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
