FDA is changing the therapeutic equivalence rating for Accord ...
FDA is concerned that the peak blood concentration of tacrolimus for Accord Healthcare Inc.’s generic tacrolimus oral capsules may be increased compared to the brand-name drug, Prograf...
Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One …
Dec 24, 2024 · Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus ...
Astellas Issues Recall of One Lot of Prograf 0.5 mg and One Lot of ...
Dec 23, 2024 · Astagraf XL® (tacrolimus extended-release capsules) 0.5 mg capsules. 30 capsules per bottle. 0469-0647-73. 0R3092A. 03/2026. ... Subscribe to our newsletter for the latest medication news, new drug approvals and FDA alerts.
Accord Healthcare’s Tacrolimus Oral Capsules No Longer ... - MPR
Sep 19, 2023 · According to study findings, Accord Healthcare’s tacrolimus oral capsules may deliver elevated peak blood concentrations compared with the brand name drug leading to an increased risk for...
Recent food recalls: Here's what FDA has recalled in January so far
3 days ago · Systane’s Lubricant Eye Drugs. Recalled due to Fungal Contamination Astellas’ Tacrolimus and Tacrolimus Extended-Release capsules. Recalled because bottles may contain empty capsules
FDA changes therapeutic equivalence rating for Accord …
Sep 23, 2023 · Based on new data, the US FDA is changing the therapeutic equivalence rating for Accord Healthcare's generic tacrolimus oral capsules, which are indicated for the prevention of rejection in adults receiving kidney, liver or heart transplants, and in pediatric patients receiving liver transplants.
Tacrolimus news and latest updates - Medical Xpress
Study: Black kidney transplant patients exhibit faster clearance rates of key immunosuppressive medicine tacrolimus
Questions and Answers Regarding Tacrolimus Oral Capsules …
Sep 27, 2023 · 1. What is tacrolimus? Tacrolimus oral capsules are drugs approved by FDA for prevention of organ rejection in adult and pediatric patients who received certain types of organ transplants.
TFF Pharmaceuticals Provides Update on Tacrolimus Inhalation …
May 15, 2024 · Variability in Systemic Exposure to Tacrolimus Was Reduced with TFF TAC Which Could Lower Risk of Acute Rejection and Systemic Toxicities.
Astellas recalls two lots of tacrolimus due to empty capsules
6 days ago · Astellas recalls two lots of tacrolimus due to empty capsules. News item; Published: 04 January 2025; Volume 2040, page 2, (2025) ... (Tacrolimus) and One Lot of ASTAGRAF XL 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules Internet Document : 30 Dec 2024.