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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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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns.

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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OPDP Says TV Ad is Out of Bounds with Fourth Untitled Letter of 2024

FDA Law Blog: Biosimilars

The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence.

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Contents

RX Note

G6PD Deficiency - Explaining G6PD Deficiency Ramadan - Medications during Ramadan fasting Adverse Drug Reactions Adverse Drug Reactions - All adverse reactions are adverse drug event Pharmacovigilance - To detect unreported ADRs Drug Allergy - Management vary based on the signs and symptoms Medicine-induced Discolouration - Red?