The FDA Law Blog

DECEMBER 15, 2022

In 2017, it decided to withdraw the compliance policy guide (CPG; from 1988) under which, for decades, the Agency essentially had permitted the marketing of over-the-counter homeopathic drug products. It issued a draft guidance in 2017 which was subsequently revised in 2019.

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The FDA Law Blog

NOVEMBER 6, 2024

The Court looked to the “statute’s words, structure, and historical context” and found that they “establish that, when Congress amended the [Orphan Drug Act] in 2017, it ratified and incorporated the existing regulatory definition of ‘same drug’ into the statute.”

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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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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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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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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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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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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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The Checkup by Singlecare

FEBRUARY 19, 2024

Rybelsus is the first oral form of semaglutide, approved in 2017. The drug label for Ozempic specifically states it can be used to help reduce the risk of cardiovascular events like heart attacks and stroke in people with Type 2 diabetes and heart disease. This indication is not found on the label for Rybelsus.

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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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The Checkup by Singlecare

DECEMBER 21, 2023

Though metformin isn’t technically approved for use in treating anything other than diabetes, many healthcare providers prescribe it off-label because of the growing body of evidence supporting these added benefits. What is metformin approved to treat?

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The Checkup by Singlecare

OCTOBER 12, 2023

Abilify generic | Abilify vs. aripiprazole | Cost | Off-label use | How to switch Abilify is a brand-name medication approved to treat certain mental health conditions, including the treatment for schizophrenia , bipolar disorder , and major depressive disorder. Using an approved drug for an unapproved use is called off-label use.

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pharmaphorum

NOVEMBER 6, 2022

The antibody-based drug has been cleared by the European Commission with a broad label, covering both full-term and pre-term babies and those with a range of health conditions that could make the vulnerable to RSV, said the two pharma groups in a statement. It is the first approval for Beyfortus (nirsevimab) by any regulatory authority.

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The Checkup by Singlecare

JULY 3, 2024

Doctors prescribe gabapentin off-label for several other medical conditions, including general neuropathic pain, bipolar disorder, anxiety, fibromyalgia, and migraines. At this time, seven states label gabapentin as a controlled substance. In 2021, 70.9 million gabapentin prescriptions were dispensed by U.S. pharmacies.

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The Checkup by Singlecare

NOVEMBER 13, 2024

Metformin is a generic oral diabetes medication that helps people with Type 2 diabetes control their blood sugar and is often used off-label as a treatment for polycystic ovarian syndrome (PCOS). Would I be taking either of these drugs off-label (for a use not approved by the FDA)?

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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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pharmaphorum

NOVEMBER 14, 2022

The narrower label for Zejula (niraparib) means it can only be used as second-line maintenance therapy after platinum-based chemotherapy in patients with these cancers whose tumours carry a germline BRCA mutation – around 15% of the population. That was due last Friday, but cancelled when GSK opted to withdraw the approval.

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The Checkup by Singlecare

OCTOBER 9, 2024

Its first approval was in 2017 for atopic dermatitis (eczema). However, it’s shown some versatility in recent studies , so doctors might prescribe it off-label for other skin conditions that aren’t FDA approved. The issue is that many health plans won’t extend medical benefits for off-label prescriptions.

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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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The FDA Law Blog

SEPTEMBER 28, 2023

Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs. While Marschall was convicted of a felony based on one earlier 2017 FDC Act conviction, in a footnote, the 9th Circuit notes that this was actually Marschall’s third FDC Act conviction.

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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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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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pharmaphorum

SEPTEMBER 21, 2020

The committee also recommended Lynparza should get its label extended to cover first-line maintenance treatment of ovarian cancer in combination with Roche’s Avastin (bevacizumab), in patients with homologous recombination deficient (HRD)-positive disease.

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The Checkup by Singlecare

NOVEMBER 11, 2024

Although trazodone is FDA -approved for depression, it’s primarily known for its off-label use as a sleep aid due to its sedative effects. In a 2017 systematic review , researchers concluded that low-dose trazodone is effective for insomnia in people with or without depression.

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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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pharmaphorum

DECEMBER 18, 2020

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

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The Checkup by Singlecare

OCTOBER 30, 2023

According to a 2017 database review , no evidence of drug interactions between hormonal contraception and non-rifamycin antibiotics was found. Amoxicillin food interactions According to the amoxicillin product labeling , there are no drug-food interactions of concern.

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The Checkup by Singlecare

JULY 9, 2024

However, some doctors prescribe Latuda off-label for depression or depressive episodes in bipolar II disorder. It is also FDA approved as a bipolar I disorder maintenance treatment for patients 7 years and older. Those are the FDA-approved uses, or indications, for Latuda and lithium.

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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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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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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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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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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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The Checkup by Singlecare

DECEMBER 15, 2022

Reporterlinker , 2017). A survey in the UK looked at cyberbullying across social media platforms in 2017. Ditch the Label , 2017). Ditch the Label , 2017). Ditch the Label , 2017). Reportlinker , 2017). The annual bullying survey 2017 ( Ditch the Label ). About 16% of U.S.

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Pharmaceutical Technology

APRIL 28, 2023

Originally granted approval in its largest market, the US, in 2017, Ozempic has subsequently obtained approval for three distinct dosages, 0.5mg, 1.0mg, and 2.0mg, for the treatment of type 2 diabetes.

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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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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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