The FDA Law Blog

MARCH 5, 2024

Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.

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Labelling FDA 59

STAT

JUNE 29, 2023

He allegedly worked with several other individuals and pharmacies between 2017 and 2021 as part of the scheme. Reconfiguring bottles and labels for distributing medicines is known as misbranding or diverting legitimate prescription drugs. Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y.,

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Labelling FDA 97

The Checkup by Singlecare

NOVEMBER 4, 2024

A 2017 study found significant reductions in blood lipids (including triglycerides and total cholesterol) in people taking supplemental cinnamon. The study of cinnamon and blood sugar levels involves many variables.

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Compounding People Management Dosage Labelling 95

pharmaphorum

MARCH 1, 2021

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups.

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Labelling FDA 105

The Checkup by Singlecare

AUGUST 14, 2024

Although GLP-1 drugs have been around since 2005, Ozempic was only made available in 2017. Taking medication for a reason that isn’t FDA approved is considered an “ off-label ” use. First, using a drug off-label—especially one that’s fairly new, like Ozempic—can be unsafe.

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Labelling FDA Insurance Insurance Coverage 88

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group. .

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Labelling 105

European Pharmaceutical Review

APRIL 8, 2024

The expanded label of CARVYKTI has the potential to transform the treatment paradigm for multiple myeloma by providing patients and physicians with a personalised immunotherapy that can be used earlier in the treatment regimen,” commented Ying Huang, PhD, Chief Executive Officer of Legend Biotech.

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FDA Labelling 98

European Pharmaceutical Review

JULY 27, 2023

Soliris was first approved the EU in 2017 as a treatment for gMG. Patients who completed the randomised control period were eligible to continue into an open-label extension period evaluating the safety and efficacy of Soliris, which is ongoing.

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Labelling Hospitals 98

pharmaphorum

MARCH 23, 2021

The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis. Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analysed to inform next steps on this study.

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Labelling 98

pharmaphorum

NOVEMBER 1, 2021

The full approval for T315I-positive CML came on the back of a non-randomised, open-label phase 1 trial involving 330 patients that is also looking at combinations of Scemblix with other TKIs. The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

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FDA Labelling 115

The Checkup by Singlecare

MARCH 10, 2025

Although metformin is only approved for the treatment of Type 2 diabetes, it has several off-label uses, including in the treatment of polycystic ovarian syndrome (PCOS). Its a member of the biguanide class of medications and is sometimes sold under the brand name Riomet. Metformin dosage for PCOS Both Drs.

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Dosage Labelling Hospitals 59

pharmaphorum

SEPTEMBER 11, 2020

Ocrevus (ocrelizumab) was approved in 2017 for relapsing and primary progressive forms of MS and is seen as one of the most successful drug launches in pharma history, generating sales of $3.79 Roche has hit back at Novartis’ newly-approved multiple sclerosis drug Kesimpta, with new data from its already-marketed blockbuster Ocrevus.

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Labelling FDA 86

pharmaphorum

MARCH 8, 2021

The new indication for the Merck & Co/MSD-partnered drug – which is also used to treat ovarian, breast and pancreatic cancer – was approved by the EMA last year with a slightly more restricted label than was previous cleared by the FDA.

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Chemotherapy Labelling FDA 98

pharmaphorum

FEBRUARY 8, 2021

Breyanzi has however been cleared with a similar black box warning on its label for neurotoxicity and cytokine release syndrome (CRS) as Novartis and Gilead/Kite’s therapies. At the moment there are limited fallback options for patients whose lymphoma progresses despite first line chemotherapy and anti-CD20 treatment.

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FDA Chemotherapy Labelling 111

Hospital Pharmacy Europe

APRIL 4, 2024

Cladribine tablets (brand name Mavenclad) have been granted a label extension by the Medicines and Healthcare products Regulatory Agency (MHRA) to expand access for additional patient populations with multiple sclerosis (MS), its manufacturer Merck has announced.

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Labelling Hospitals 52

pharmaphorum

MARCH 9, 2022

The launch of Hemlibra (emicizumab) in 2017, with a label expansion in 2018 to broaden its use – had a speedy impact on Eloctate, which also came from Bioverativ’s stable. Sanofi recorded a $2 billion charge in 2019 that it said was largely down to pressure on its drug.

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Labelling FDA 98

The Checkup by Singlecare

JANUARY 26, 2024

Approved by the Food and Drug Administration (FDA) in 2017 for blood sugar management, Ozempic has recently gained attention for its weight loss effects. Healthcare professionals prescribe Ozempic off-label for weight management for patients with obesity.

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Labelling FDA 111

pharmaphorum

DECEMBER 29, 2021

Dupixent (dupilumab) – an IL-4 and IL-13 inhibitor – has dominated the market for biological therapies for atopic dermatitis since it was approved by the FDA in 2017. Dupixent’s label currently calls for dosing every two weeks for all patients. Leo now says it will start rolling the new product out in February.

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FDA Labelling 111

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA).

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Documentation Labelling Hospitals 111

The Checkup by Singlecare

NOVEMBER 13, 2023

Always tell your pharmacist or provider all of the medications and supplements you are taking and read all the labels and pharmacy instructions before taking ibuprofen with any other medications. However, gastrointestinal issues may be reduced when ibuprofen is taken with food, milk, or antacids. What is the standard ibuprofen dosage?

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Dosage Labelling 105

pharmaphorum

APRIL 30, 2021

BMS and bluebird had been hoping for a label allowing third-line use. Janssen entered into a worldwide collaboration and license agreement for cilta-cel with the drug’s originator – China’s Legend Biotech – in December 2017.

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Immunization FDA Labelling 82

The Checkup by Singlecare

FEBRUARY 13, 2023

A 2017 meta-review of 11 randomized controlled trials found that participants who took a dose that ranged between 365 to 450 mg per day experienced decreases in both systolic and diastolic blood pressure. Read the labels. The FDA encourages people to read the directions and take the supplement only as described on the label.

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Mayo Clinic Labelling FDA 119

pharmaphorum

OCTOBER 14, 2021

The findings were based on an ALITHIOS Phase 3b open-label extension study of Kesimpta, a targeted B-cell therapy that Novartis says, “delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment for MS.”. years vs initiation two years later. billion in 2019.

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Labelling Immunization FDA 59

The Checkup by Singlecare

DECEMBER 31, 2024

It also has several off-label uses (uses not approved by the FDA), such as treating heart failure. Losartan is a generic medication used to treat a variety of conditions. It is approved by the Food and Drug Administration (FDA) to treat hypertension (high blood pressure) and diabetic nephropathy.

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FDA Labelling 52

The Checkup by Singlecare

NOVEMBER 3, 2023

Read food labels carefully. When buying packaged foods, carefully scan the label and look for added sugars. “Fruits are and should be one of the main components in our daily meals,” says Dr. Makhija. Fruit is a power-packed food and provides nutrients beyond the ‘sweet’ component of it.” Added sugar can go by many names.

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Labelling Packaging Immunization 116

Pharma Marketing Network

MARCH 25, 2022

Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Connect at linkedin.com/in/sunnywhite/ . REFERENCES: Gilda’s Club.

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Labelling FDA 98

The Checkup by Singlecare

DECEMBER 13, 2024

However, those same effects make these medications an effective off-label treatment for anxiety. Although it is used off-label, it can be beneficial in managing symptoms of anxiety and help avoid the use of stronger, more addictive drugs, like benzodiazepines , explains Zishan Khan, MD , a psychiatrist with MindPath Health in Frisco, Texas.

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Controlled Substances Labelling Dosage FDA 81

pharmaphorum

MARCH 16, 2022

The Belgian biotech, which was spun out from the Vrije Universiteit Brussel in 2014, is developing a pipeline of radio-labelled, single-chain antibodies led by CAM-H2, currently in a phase 1/2 study in patients with HER2-positive metastatic breast and gastric cancers.

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Labelling 59

pharmaphorum

OCTOBER 7, 2021

In 2017, Teva won approval for Austedo (deutetrabenazine), a tweaked version of tetrabenazine that also claims to offer fewer side effects, but carries a black box warning for depression and suicidality. Sales were $638 million last year and according to Teva will approach the $1 billion mark in 2021, despite the warning label.

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Labelling 72

The Checkup by Singlecare

NOVEMBER 8, 2023

It gained approval in 2017 but has surged in popularity recently due to the medication’s ability to help with weight loss. You’ve likely heard about Ozempic (semaglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist approved by the Food & Drug Administration (FDA) to manage blood sugar levels for people with Type 2 diabetes.

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FDA Labelling 105

pharmaphorum

JULY 8, 2021

If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by high levels of eosinophils – a type of white blood cell. Results from that programme are due in 2023.

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FDA Labelling 52

pharmaphorum

MARCH 3, 2021

Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009. A further approval in 2017 in childhood asthma has helped the drug to build sales in the US.

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Labelling FDA 52

Pharmaceutical Technology

JANUARY 23, 2023

Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients. In addition to Skyrizi’s recent supplementary CD indication, both Tremfya and Skyrizi received US FDA approval in psoriasis in 2017 and in 2019, respectively.

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Compounding Labelling FDA 59

pharmaphorum

MARCH 11, 2022

Vraylar, sold in some markets as Reagila, was first approved in 2015 for schizophrenia and bipolar disorder, with its label extended in 2017 to include maintenance treatment of schizophrenia and again in 2019 for bipolar depression.

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Labelling 52

The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. Ozempic is a brand name for the prescription drug semaglutide, which was originally developed for Type 2 diabetes management.

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Insurance Insurance Coverage FDA Documentation 104

pharmaphorum

SEPTEMBER 16, 2022

As Dr Thyssen further explained, “[i]t all started with the approval of the first biologic in 2017, and has been followed by the approval of other drugs, including one biologic and [three] oral drugs, in the past [one to two] years.

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Medical Schools Hospitals Dosage Labelling 100

pharmaphorum

JANUARY 5, 2023

In 2017, reSET became the first FDA-approved DTx with both a safety and efficacy label, after the US regulator licensed it for substance use disorders involving alcohol, cocaine, marijuana, and stimulants. Pear secured approval for reSET-O in the following year.

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Labelling FDA 52