NDA 202799, held by Takeda Pharms USA. Peginesatide Acetate.
As of Nov 13, 2026, NDA 202799 (Omontys Preservative Free, Omontys), held by Takeda Pharms USA, was first approved by FDA on Mar 27, 2012, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 2012 | Original applicationNew molecular entity · Standard review | Approved |
| Omontys Preservative FreeEQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) · solution;intravenous, subcutaneous | Peginesatide Acetate | Discontinued |
| Omontys Preservative FreeEQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) · solution;intravenous, subcutaneous | Peginesatide Acetate | Discontinued |
| Omontys Preservative FreeEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) · solution;intravenous, subcutaneous | Peginesatide Acetate | Discontinued |
| Omontys Preservative FreeEQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) · solution;intravenous, subcutaneous | Peginesatide Acetate | Discontinued |
| Omontys Preservative FreeEQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) · solution;intravenous, subcutaneous | Peginesatide Acetate | Discontinued |
| Omontys Preservative FreeEQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) · solution;intravenous, subcutaneous | Peginesatide Acetate | Discontinued |
| OmontysEQ 10MG BASE/ML (EQ 10MG BASE/ML) · solution;intravenous, subcutaneous | Peginesatide Acetate | Discontinued |
| OmontysEQ 20MG BASE/2ML (EQ 10MG BASE/ML) · solution;intravenous, subcutaneous | Peginesatide Acetate | Discontinued |
| Dec 4, 2012 | Supplement 1Labeling · Standard review | Approved | |
| Mar 27, 2012 | Original applicationNew molecular entity · 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
