The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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FDA Documentation Packaging Communication 75

pharmaphorum

NOVEMBER 9, 2022

AstraZeneca has moved a step closer to bringing a first-in-class drug to market in the US that can be used to reduce severe asthma attacks, after an FDA advisory committee voted in favour of approval. AZ is developing PT027 with UK partner Avillion under the terms of an agreement first signed in 2018.

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FDA Labelling 59

pharmaphorum

DECEMBER 16, 2020

An FDA advisory committee 12 to 1 in favour of approving Entresto (sacubitril/valsartan) for heart failure with preserved ejection fraction (HFpEF), which accounts for around half of all heart failure cases but proves highly resistant to drug treatment. The post Entresto set for big sales hike after FDA panel endorsement appeared first on.

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FDA Labelling 52

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

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. . The post Apellis set to take on Alexion as FDA clears PNH drug Empaveli appeared first on.

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FDA Labelling Vaccines 52

pharmaphorum

OCTOBER 19, 2020

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results.

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Adverse Reactions FDA Chemotherapy Labelling 59

pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. The post Dermavant claims its first approval as FDA clears psoriasis drug appeared first on.

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FDA Labelling 52

pharmaphorum

APRIL 23, 2021

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 While some argued that GSK overpaid for Tesaro in 2018, at least the deal is bringing badly needed new drugs to market for the under-pressure UK pharma and its highly-paid research chief Hal Barron.

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FDA Chemotherapy Labelling 52

pharmaphorum

JUNE 23, 2021

Keytruda (pembrolizumab) was given an accelerated approval in 2018 as a second-line therapy for PD-L1-positive cervical cancer, but the new survival data – from the phase 3 KEYNOTE-826 trial – could extend the use of the drug.

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Chemotherapy FDA Labelling 85

pharmaphorum

AUGUST 4, 2022

Keytruda has struggled to make an impact in prostate cancer, and the disease does not feature on the drug’s very long list of approved indications, despite considerable clinical testing on Merck’s part, or indeed on the label’ of other drugs in the PD-1/PD-L1 inhibitor class like Bristol-Myers Squibb’s Opdivo (nivolumab).

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Chemotherapy Labelling FDA 105

pharmaphorum

FEBRUARY 7, 2022

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. The post Sanofi claims FDA okay for drug to treat rare blood disorder CAD appeared first on.

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FDA Labelling Immunization Vaccines 52

Hospital Pharmacy Europe

JUNE 12, 2023

Dystrophic epidermolysis bullosa is caused by a gene mutation, and the recent FDA approval of the corrective gene therapy VYJUVEK represents the first specific treatment to become available. The FDA approval of VYJUVEK – also known as beremagene geperpavec or B-VEC – provides the first novel topical gene therapy.

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FDA Labelling Hospitals 96

Pharmaceutical Technology

JULY 29, 2022

While the prevalence was 1 in 150 children in 2000, it reached the rate of 1 in 44 in 2018, in the US, according to the Centers for Disease Control and Prevention. Off-label medication options. The rate at which children are being identified with autism spectrum disorder (ASD) has tripled in the past two decades.

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Communication Labelling Hospitals FDA 105

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation.

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FDA Communication Chemotherapy Labelling 52

The Checkup by Singlecare

MARCH 22, 2023

In fact, a 2018 study found that, on average, Americans pay more than two-and-a-half times as much for prescription drugs as citizens of 32 other countries involved in the study. We have a regulator called Health Canada, similar to the Food and Drug Administration (FDA), which works to ensure the safety of our drugs,” Tadrous says.

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Health and Personal Care Stores Controlled Substances Dosage FDA 105

The Checkup by Singlecare

AUGUST 8, 2024

A study from 2018 confirmed its antihistamine effect in dogs. She also explains that “Zyrtec’s use for dogs is ‘ off-label.'” Check the drug’s packaging and label carefully before giving it to your pet. Standard Zyrtec, with no decongestants, can be given to dogs. How quickly does Zyrtec work in dogs?

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Dosage Labelling Packaging Immunization 96

European Pharmaceutical Review

OCTOBER 19, 2023

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. He also oversaw the development of Azedra a targeted radiotherapeutic recently approved by the US FDA for the treatment of rare tumors of the adrenal gland.​

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Chemotherapy Compounding Immunization FDA 105

The Checkup by Singlecare

JANUARY 4, 2024

In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day. In addition, the FDA advises against mixing alcohol with OTC medicines containing decongestants like pseudoephedrine or phenylephrine. appeared first on The Checkup.

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Immunization Labelling Dosage Medication Labelling 102

The Checkup by Singlecare

JULY 8, 2024

The Food & Drug Administration (FDA) has approved Rinvoq to treat: Atopic dermatitis Rheumatoid arthritis Psoriatic arthritis Ulcerative colitis Crohn’s disease Ankylosing spondylitis Non-radiographic axial spondyloarthritis This article will unpack the benefits, dosage, side effects, and risks of Rinvoq for atopic dermatitis.

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Insurance Dosage Immunization Labelling 97

pharmaphorum

NOVEMBER 10, 2022

However, turnover fell back to $148 million in 2021, mainly as a result of strong competition from AstraZeneca and Merck & Co’s class-leading Lynparza (olaparib) – which has a much broader product label – as well as GSK’s Zejula (niraparib). With finances tight, Clovis has deferred a $1.9

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Chemotherapy Labelling FDA 59

pharmaphorum

JANUARY 5, 2021

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

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Chemotherapy Immunization FDA Labelling 52

The Checkup by Singlecare

FEBRUARY 5, 2024

Food and Drug Administration (FDA) for relief of mild, intermittent asthma symptoms, like wheezing, cough, shortness of breath, and chest tightness. Primatene Mist was actually taken off the market in 2011 due to CFC use and not reintroduced until 2018 in the HFA form. OTC inhalers are approved by the U.S.

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Labelling FDA Dosage 52

pharmaphorum

MARCH 24, 2022

Novartis has been steadily investing in radiopharmaceuticals over the last few years, and one of those deals has just paid off with an FDA approval for Pluvicto, the first targeted radioligand therapy for prostate cancer. After a median follow-up of 20.9 months, patients on Pluvicto had radiographic progression-free survival (PFS) of 8.7

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Chemotherapy Labelling FDA 59

The Checkup by Singlecare

FEBRUARY 1, 2024

Keep a regular schedule : Taking ibuprofen as directed by the label or a healthcare provider can help ensure the drug is taken effectively and safely. Read labels on nonprescription products: Check the labels of OTC cold and pain medications. Many products contain ibuprofen and other NSAIDs as added ingredients.

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Labelling Dosage FDA 98

The FDA Law Blog

FEBRUARY 14, 2023

Gaulkin & Riëtte van Laack — Chocolate-lovers and hopeless romantics rejoice: FDA has announced that it does not intend to object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease. By Sophia R.

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FDA Labelling 40

The Checkup by Singlecare

FEBRUARY 13, 2023

A 2018 meta-review of multiple studies involving CoQ10 supplementation found that CoQ10 significantly decreased systolic blood pressure–that’s the top number on a blood pressure reading–in 17 randomized controlled trials. Read the labels. CoQ10 Coenzyme Q10 , or CoQ10, is often heralded for its antioxidant properties.

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Mayo Clinic Labelling FDA 119

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. GSK acquired Zejula as part of its $5.1

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Labelling Chemotherapy FDA Vaccines 52

The Checkup by Singlecare

OCTOBER 25, 2023

UCLA Health (2018) Mobic label , U.S. Some of the most commonly reported side effects of meloxicam are: Diarrhea or constipation Upper respiratory tract infections Heartburn Flu-like symptoms Drowsiness According to the U.S.

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Mayo Clinic Controlled Substances Compounding Dosage 105

pharmaphorum

DECEMBER 8, 2021

Acadia has indicated previously that most patients who completed the LAVENDER trial have entered an open-label extension, which backs up the idea that the side effects are manageable. At 12 weeks, trofinetide-treated patients had a 5.1-point point reduction in the Rett Syndrome Behaviour Questionnaire (RSBQ) scale, compared to a 1.7-point

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Labelling FDA 59

pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Myth 2: Implementing an ECA requires too much money, time and resource.

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FDA Insurance Coverage Documentation Pharmaceutical Companies 89

The Checkup by Singlecare

DECEMBER 1, 2023

Red Dye 40 is among the most commonly used artificial food dyes in the United States, and you might see it labeled under a different name on the products you consume. Regardless of what manufacturers label it as, there have been ties to specific negative side effects when ingested too frequently. 40 Aluminum Lake, and FD&C Red No.

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Labelling FDA Documentation 52

The Checkup by Singlecare

NOVEMBER 30, 2023

Gabapentin is a generic medication approved by the Food and Drug Administration (FDA) to treat postherpetic neuralgia (nerve pain after shingles), epilepsy, other seizure disorders, and restless leg syndrome. Off-label use is when a drug is used for a purpose other than what it is approved for.

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Labelling Dosage FDA Communication 52

pharmaphorum

MARCH 3, 2021

The court case stems from October 2018, when AstraZeneca began litigation against Mylan and subsequently against 3M Company (3M) asserting infringement of various US patents covering Symbicort. Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009.

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Labelling FDA 52

The Checkup by Singlecare

OCTOBER 7, 2024

For example, results from a 2018 study demonstrated “a strong inverse association between metformin and liver cancer,” and a systematic review and meta-analysis from 2016 found a significant improvement in survival rates for diabetic liver cancer patients. The daily dosage shouldn’t exceed 2550 mg.

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Dosage Labelling FDA 98

The Checkup by Singlecare

DECEMBER 5, 2023

Levothyroxine (a thyroid hormone) is FDA approved to treat hypothyroidism , a condition in which the body produces less thyroid hormone than your body needs. It’s FDA approved to treat attention-deficit/hyperactivity disorder (ADHD) symptoms, including inattention, hyperactivity, and impulsivity. Approximately 1.2%

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Mayo Clinic Department of Veterans Affairs Labelling Medical Schools 105

The Checkup by Singlecare

MAY 20, 2024

Food and Drug Administration (FDA) to treat symptoms of ADHD, as well as narcolepsy. Ideally, that place will be dry and at room temperature, which means 68° to 77°F, according to the FDA label. Strattera (atomoxetine) was the first non-stimulant treatment the FDA approved for ADHD treatment.

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Controlled Substances FDA Labelling Insurance 96

Hospital Pharmacy Europe

MARCH 21, 2024

2 The first drug produced through printing technology based on inkjet on powder was approved by the US FDA in 2015. One of the first trials was carried out in 2017 and assessed the acceptability of printed medicines in an open-label, randomised, exploratory pilot study of 50 participants. Int J Pharm 2018 ; 548:586–96 Vaz VM, Kumar L.

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Hospitals Compounding Dosage FDA 111