USPI label updates January 2021
USPI label updates January 2021
The United States Prescription Information (USPI) is a key tool for sharing the benefits and risks of a prescription drug approved by the Food and Drug Administration (FDA).
In January 2021, approximately 42 Drug Safety-related Labeling Changes occurred.
One or more subsequent sections have been updated in each product label update.
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Drug Interactions
- Boxed Warning
- Use in Special Populations
- Patient Counseling Information
- Patient Information
- Medication Guide
USPI label updates January 2021
| Supplement Date | Drug Name | Active Ingredient | Application Type | FDA Database Updated |
| 01/15/2021 | AZULFIDINE | SULFASALAZINE | NDA | 01/22/2021 |
| 01/08/2021 | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | NDA | 01/11/2021 | |
| 01/19/2021 | BLOXIVERZ | NEOSTIGMINE METHYLSULFATE | NDA | 01/22/2021 |
| 01/22/2021 | BRIDION | SUGAMMADEX SODIUM | NDA | 01/28/2021 |
| 01/22/2021 | CABOMETYX | CABOZANTINIB S-MALATE | NDA | 01/25/2021 |
| 01/07/2021 | CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | NDA | 01/21/2021 |
| 01/22/2021 | CARBAGLU | CARGLUMIC ACID | NDA | 01/28/2021 |
| 01/11/2021 | DARZALEX FASPRO | DARATUMUMAB;HYALURONIDASE-FIHJ | BLA | 01/15/2021 |
| 01/13/2021 | DOCETAXEL | DOCETAXEL | NDA | 01/15/2021 |
| 01/21/2021 | EDURANT | RILPIVIRINE HYDROCHLORIDE | NDA | 01/28/2021 |
| 01/15/2021 | ENHERTU | FAM-TRASTUZUMAB DERUXTECAN-NXKI | BLA | 01/19/2021 |
| 01/29/2021 | FIRVANQ KIT | VANCOMYCIN HYDROCHLORIDE | NDA | 02/01/2021 |
| 01/29/2021 | GATTEX KIT | TEDUGLUTIDE RECOMBINANT | NDA | 02/01/2021 |
| 01/14/2021 | GIMOTI | METOCLOPRAMIDE HYDROCHLORIDE | NDA | 01/19/2021 |
| 01/26/2021 | GLUCAGON | GLUCAGON RECOMBINANT | NDA | 02/04/2021 |
| 01/14/2021 | JELMYTO | MITOMYCIN | NDA | 01/19/2021 |
| 01/22/2021 | LORBRENA | LORLATINIB | NDA | 01/28/2021 |
| 01/23/2021 | MAYZENT | SIPONIMOD FUMARIC ACID | NDA | 01/28/2021 |
| 01/05/2021 | NEUPOGEN | FILGRASTIM | BLA | 01/12/2021 |
| 01/13/2021 | NITHIODOTE | SODIUM NITRITE; SODIUM THIOSULFATE | NDA | 01/15/2021 |
| 01/28/2021 | NPLATE | ROMIPLOSTIM | BLA | 02/01/2021 |
| 01/07/2021 | NUBEQA | DAROLUTAMIDE | NDA | 01/11/2021 |
| 01/22/2021 | OPDIVO | NIVOLUMAB | BLA | 01/25/2021 |
| 01/29/2021 | PLEGRIDY | PEGINTERFERON BETA-1A | BLA | 01/29/2021 |
| 01/06/2021 | QVAR REDIHALER | BECLOMETHASONE DIPROPIONATE | NDA | 01/12/2021 |
| 01/28/2021 | RAPIVAB | PERAMIVIR | NDA | 02/01/2021 |
| 01/28/2021 | RETEVMO | SELPERCATINIB | NDA | 02/01/2021 |
| 01/13/2021 | SODIUM NITRITE | SODIUM NITRITE | NDA | 01/15/2021 |
| 01/19/2021 | SPRITAM | LEVETIRACETAM | NDA | 01/22/2021 |
| 01/29/2021 | TECFIDERA | DIMETHYL FUMARATE | NDA | 02/01/2021 |
| 01/22/2021 | TRINTELLIX | VORTIOXETINE HYDROBROMIDE | NDA | 01/29/2021 |
| 01/29/2021 | VANCOCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | NDA | 02/01/2021 |
| 01/29/2021 | VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER | VANCOMYCIN HYDROCHLORIDE | NDA | 02/01/2021 |
| 01/29/2021 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | NDA | 02/01/2021 |
| 01/29/2021 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | NDA | 02/01/2021 |
| 01/25/2021 | VFEND | VORICONAZOLE | NDA | 02/01/2021 |
| 01/25/2021 | VFEND | VORICONAZOLE | NDA | 02/01/2021 |
| 01/25/2021 | VFEND | VORICONAZOLE | NDA | 02/01/2021 |
| 01/29/2021 | VUMERITY | DIROXIMEL FUMARATE | NDA | 02/01/2021 |
| 01/14/2021 | XALKORI | CRIZOTINIB | NDA | 01/15/2021 |
| 01/28/2021 | XARELTO | RIVAROXABAN | NDA | 02/01/2021 |
| 01/28/2021 | XARELTO | RIVAROXABAN | NDA | 02/01/2021 |
To know each product updates@ Drug Safety-related Labeling Changes (SrLC) Click Here
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