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FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis.

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Mitomycin Intravesical Solution Receives FDA Approval for Non-Muscle Invasive Bladder Cancer

Pharmacy Times

3 The safety profile was favorable with the most common adverse effect (AE) being increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.

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Donanemab-Azbt Receives FDA Label Update With New Dosing for Alzheimer Disease

Pharmacy Times

The FDA has approved an updated label with a new recommended titration dosing schedule for donanemab-azbt (Kisunla; Eli Lilly and Company) for once-monthly amyloid-targeting therapy for adults that experience early symptomatic Alzheimer disease (AD). million individuals in the United States aged 65 and older.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. IW: What are some of the more common adverse reactions that people have to LDN? It’s also best to work with a compounding pharmacy that can help you titrate your dose correctly.

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World Standards Day: Recognizing How Standards Enable a Strong Medicines Supply Chain

Quality Matters

There are also related standards that address a wide range of topics such as packaging, storage and distribution of medicines, the preparation of compounded medicines and prescription labeling. USP engaged its scientific committee and quickly developed standards to support the production of quality hand sanitizers.