Recall Impacts Exela and Civica Brands
In total, 11 lots of three different products have been recalled because of silicone found in retained samples.
Several Lots of Sandimmune Involved in Two Recall Efforts
Crystal formation observed Sandimmune Oral Solution (cyclosporine), which is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.
Stability and Purity Issues Lead to Recall of Tydemy
One of the two recalled lots of the birth control tested high for a known impurity.
Subpotency Leads to Recall of 27 Lots of Tirosint-SOL
IBSA Pharma is recalling the hypothyroid medication because analyses showed lowered levels of levothyroxine in some lots.
FDA Warns About Certain Compounded Semaglutide Products
The FDA has received adverse event reports after patients have used compounded semaglutide that contains salt formulations, which are different active ingredients than that used in the agency-approved drugs for diabetes and weight loss.
Skyrizi Overtakes Humira in U.S. Sales Numbers
November 8th 2024For the first time, Skyrizi has replaced Humira as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
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FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
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