The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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The Checkup by Singlecare

NOVEMBER 30, 2023

Acetaminophen may also blunt the effects of other medications that impact the immune system, including some medicines used to manage cancer diagnoses and even the immune response following vaccinations. In some cases, metyrapone is used off-label in the treatment of Cushing syndrome.

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pharmaphorum

MAY 17, 2021

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . billion and $1.1 billion respectively last year, although Soliris could lose patent protection next year.

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The People's Pharmacy

MAY 29, 2023

According to my European colleagues it is prescribed off-label for this purpose. A reader of this column notified us several years ago that his medical colleagues in Europe prescribed cimetidine off label to treat shingles and z oster- a ssociated p ain ( ZAP ). We searched high and low for research to support this unique strategy.

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IDStewardship

JULY 27, 2022

At the same time, there were multiple competing priorities, such as managing the bone infection caseloads, implementing changes to departmental IPC practice, vaccination programmes and new COVID-19 treatments. Like all AMS teams, trying to be agile and respond to this change has been an enormous challenge.

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PharmaShots

APRIL 13, 2023

Its flagship product Humira achieved a $2B global revenue Additionally, Abbott acquired Kos Pharmaceuticals and Guidant's vascular business and launched a new division, Abbott Nutrition International 2007 was a great year for Johnson & Johnson, its consumer health business showed a drastic growth of 48.3% over the previous year.

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The Checkup by Singlecare

JANUARY 22, 2024

Always follow the labeled directions for OTC and prescription medications. If a tetanus shot has not been received in the past ten years or if the burn is notably severe, seeking advice from a healthcare professional regarding a tetanus booster is recommended. Consult a healthcare provider if a burn is severe or accompanied by an open wound.

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