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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

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Europe approves Roche’s Tecentriq liver cancer combination

pharmaphorum

Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. The most frequent serious adverse reactions for the combination, occurring in 2% or more of patients, were bleeding in the gastrointestinal tract and fever.

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Fresenius Kabi introduces Vasopressin Injection, USP, in US

Pharma Leaders

Bradycardia, tachyarrhythmias, decreased cardiac output, ischemia, and hyponatremia are some of the adverse reactions on using Vasopressin. In addition to injectable medicines, Fresenius is engaged in developing, biosimilars, and technologies for transfusion, infusion, and clinical nutrition.

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Fresenius Kabi introduces Vasopressin Injection, USP, in US

Pharmaceutical Business Review

Bradycardia, tachyarrhythmias, decreased cardiac output, ischemia, and hyponatremia are some of the adverse reactions on using Vasopressin. In addition to injectable medicines, Fresenius is engaged in developing, biosimilars, and technologies for transfusion, infusion, and clinical nutrition.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Biosimilars

As a final example, current regulations require a sponsor of an investigational medical device to report to FDA (and others) “unanticipated” adverse events, which are defined in part as “serious,” and sponsors of investigational drugs to report to FDA serious and unexpected suspected adverse reactions.

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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. UBRELVY is indicated for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine.

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Lizzo has Thoughts: First Untitled Letter for Promotional Activities in a Yearwass

FDA Law Blog: Biosimilars

It has boxed warnings for hepatoxicity and QT prolongation and is contraindicated in numerous patient populations and has 17 adverse reactions with an incidence of >20%. In other words, this is a drug that requires serious risk information to be presented.