The Checkup by Singlecare

AUGUST 14, 2024

Ozempic (semaglutide) is an injectable drug approved by the Food and Drug Administration (FDA) to treat Type 2 diabetes and reduce the risk of major cardiovascular events in people with Type 2 diabetes and known heart disease. Although GLP-1 drugs have been around since 2005, Ozempic was only made available in 2017.

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Labelling FDA Insurance Insurance Coverage 52

European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). Janssen), a Johnson & Johnson company in December 2017. The partnership deal focused on the development and commercialisation of the immunotherapy CAR-T cell therapy cilta-cel.

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FDA Labelling 98

pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. The post GSK’s Benlysta claims first FDA okay for lupus kidney damage appeared first on.

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FDA Labelling 87

pharmaphorum

FEBRUARY 8, 2021

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. DLBCL is the most common type of NHL in adults, accounting for around a third of the 77,000 new cases diagnosed in the US, according to the FDA.

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FDA Chemotherapy Labelling 110

pharmaphorum

JULY 8, 2021

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Tezepelumab was awarded a breakthrough designation for non-eosinophilic asthma by the FDA in 2018. Results from that programme are due in 2023.

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FDA Labelling 52

pharmaphorum

JUNE 7, 2021

Kymriah (tisagenlecleucel) was approved for relapsed/refractory ALL in 2017, but its label covers use in children and young adults aged up to 25, who account for the bulk of cases of the blood cancer. It was filed for the adult ALL indication in the US in April, and has a priority review from the FDA, with a verdict due in October.

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FDA Labelling Immunization 105

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 95

pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. The post FDA clears first “interchangeable” Humira biosimilar appeared first on.

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FDA Labelling 40

The Checkup by Singlecare

FEBRUARY 19, 2024

Food & Drug Administration (FDA) for weight management, many people find they lose weight with these medications, especially with lifestyle changes like a healthy diet and regular exercise. Rybelsus is the first oral form of semaglutide, approved in 2017. This indication is not found on the label for Rybelsus.

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Dosage Insurance Coverage Labelling Insurance 96

The Checkup by Singlecare

DECEMBER 21, 2023

But since its FDA approval for the treatment of Type 2 diabetes back in 1994, metformin has emerged as something of a “miracle drug” thanks to its effectiveness in treating other common health conditions, like infertility, obesity , and heart disease. Metformin is a medication commonly used to treat people with Type 2 diabetes.

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Health and Personal Care Stores Labelling Dosage FDA 105

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. Abilify first received FDA approval in 2002. mL, 960 mg/3.2

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Dosage Labelling FDA Adverse Reactions 52

The Checkup by Singlecare

JULY 9, 2024

It’s also approved by the Food and Drug Administration (FDA) to treat schizophrenia. Adults, adolescents, and children 10 years and older Adults, adolescents, and children 7 years and older Latuda vs. lithium: Conditions treated Through rigorous clinical trials and documentation, the FDA approves medications for very specific uses.

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Insurance Dosage Labelling FDA 80

The FDA Law Blog

SEPTEMBER 28, 2023

Walsh — As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent. Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs.

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FDA Labelling 52

The Checkup by Singlecare

OCTOBER 9, 2024

Dupixent (dupilumab) is a brand-name monoclonal antibody drug that is approved by the Food and Drug Administration (FDA) to treat a variety of conditions. Its first approval was in 2017 for atopic dermatitis (eczema). The issue is that many health plans won’t extend medical benefits for off-label prescriptions.

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Insurance Labelling Insurance Coverage Specialty Pharmacies 52

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. But it fell short on the secondary endpoint of an improvement of a reduction in the annual rate of moderate to severe exacerabations.

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Labelling FDA 105

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. It received FDA approval for weight management in June 2021.)

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Labelling FDA 111

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). Wegovy and metformin work in different ways and are FDA approved for different uses, so it’s difficult to objectively say which one is better.

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Insurance Coverage Insurance Labelling Dosage 52

The Checkup by Singlecare

NOVEMBER 11, 2024

As a brand-name prescription drug, Lexapro is FDA -approved to treat major depressive disorder and anxiety disorders. 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.

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FDA Labelling 52

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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FDA Documentation Compounding Pharmaceutical Companies 103

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. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

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Insurance Insurance Coverage FDA Documentation 104

pharmaphorum

NOVEMBER 14, 2022

GSK has had another setback in its oncology business, after the FDA asked it to restrict use of its PARP inhibitor Zejula in ovarian, fallopian tube, or primary peritoneal cancer to patients with a specific mutation. That was due last Friday, but cancelled when GSK opted to withdraw the approval.

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Labelling Chemotherapy FDA Vaccines 52

European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

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FDA Labelling 59

PQA

DECEMBER 7, 2023

Certain classes, particularly glucagon-like peptide-1 (GLP-1) receptor agonists and the closely related glucose-dependent insulinotropic peptide-1/glucagon-like peptide (GIP/GLP-1) receptor agonists, have recently received US Food and Drug Administration (FDA) indications for weight loss in addition to diabetes treatment.

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FDA Labelling 45

The Checkup by Singlecare

OCTOBER 30, 2023

Food and Drug Administration (FDA) to treat a wide range of respiratory bacterial infections, such as pneumonia and bronchitis , as well as infections of the ear , nose, throat , urinary tract infections , and skin. Amoxicillin food interactions According to the amoxicillin product labeling , there are no drug-food interactions of concern.

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Vaccines Labelling FDA Dosage 105

pharmaphorum

JANUARY 5, 2023

The deal centres on reSET and reSET-O, Pear’s cognitive behavioural therapy (CBT) based programmes, for people living with substance and opioid use disorders, respectively, which have been approved by the FDA as an adjunct to outpatient treatment.

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Labelling FDA 52

The Checkup by Singlecare

JULY 3, 2024

Food and Drug Administration ( FDA ) for certain types of nerve pain, seizures, and restless leg syndrome. Doctors prescribe gabapentin off-label for several other medical conditions, including general neuropathic pain, bipolar disorder, anxiety, fibromyalgia, and migraines. Gabapentin is an anticonvulsant approved by the U.S.

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Controlled Substances Labelling Dosage FDA 59

pharmaphorum

APRIL 30, 2021

The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood cancer, a few months after it was submitted to the FDA for the same indication. BMS and bluebird had been hoping for a label allowing third-line use.

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Immunization FDA Labelling 72

PharmaShots

APRIL 20, 2023

Food and Drug Administration (FDA) in June 2020 as a rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. On October 14, 2022, the FDA approved Lyumjev® (insulin lispro-aabc injection), a rapid-acting mealtime insulin, for the treatment of children with diabetes.

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FDA Insurance Labelling 40

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

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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Labelling Vaccines FDA 52

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 billion in 2019 with more growth predicted this year.

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Labelling FDA 69

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

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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Compounding Dosage Labelling FDA 52

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

The Checkup by Singlecare

NOVEMBER 8, 2023

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. It gained approval in 2017 but has surged in popularity recently due to the medication’s ability to help with weight loss.

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FDA Labelling 105

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

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