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Related terms: Fluorouracil Topical

FDA Approves Safety Labeling Changes Regarding DPD Deficiency for Fluorouracil Injection Products

On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs a...

Ipsen’s Onivyde Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Adenocarcinoma, Approved by FDA

PARIS, FRANCE, 13 February 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde (...

Findings of IDEA Collaboration Have Influenced Prescribing Patterns

WEDNESDAY, Aug. 9, 2023 – Changes in prescribing patterns for resected stage III colon cancer have been observed since the abstract presentation of the IDEA collaboration in June 2017, according to...

ASCO: FOLFOX Noninferior to Chemoradiotherapy for Overall Survival in Rectal Cancer

FRIDAY, June 9, 2023 – Neoadjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) is noninferior to preoperative chemoradiotherapy with respect to overall survival for patients...

FDA Medwatch Alert: Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate

July 2, 2019 – Fresenius Kabi USA, LLC is voluntarily recalling two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the user level due to the potential for...

FDA Medwatch Alert: Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter

[Posted 07/27/2015] ISSUE: Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of...

FDA Medwatch Alert: Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter

ISSUE: Teva Parenteral Medicines issued a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified...

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