Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

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European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products. FDA’s sampling and testing programme found 892 of 1,552 product samples (57.5

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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European Pharmaceutical Review

DECEMBER 2, 2022

has announced the US Food and Drug Administration (FDA) has approved its oral drug Rezlidhia (olutasidenib) for adults with relapsed or refractory (R/R) acute myeloid leukaemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. Rigel Pharmaceuticals, Inc. Clinical safety data of Rezlidhia for AML.

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Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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The Checkup by Singlecare

MARCH 10, 2025

Some are also approved to help lower the risk of heart disease and cardiovascular events in people with diabetes or obesity. It is the active ingredient in the brand-name , FDA-approved drugs Ozempic , Wegovy , and Rybelsus. Novo Nordisk is the only pharmaceutical company that makes FDA-approved medications containing semaglutide.

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pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The post FDA clears Incyte’s Opzelura as first vitiligo therapy appeared first on.

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BuzzRx

JANUARY 27, 2023

Food and Drug Administration (FDA) has to undergo several rigorous phases before approving new medications. Once the FDA approves a new drug, it means that when using this drug for an approved condition, the potential benefits outweigh the potential risks. The term “on-label use” of a drug may seem unfamiliar to most people.

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The FDA Law Blog

SEPTEMBER 23, 2022

By Ellis Unger, Principal Drug Regulatory Expert — On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics , including sessions on new FDA Medical Queries and standardized presentations of safety data.

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The Checkup by Singlecare

APRIL 9, 2025

That means patients insured under those plans will likely have their Ozempic prescription covered by insurance for Ozempic s FDA -approved purpose: blood sugar management for Type 2 diabetes. Though some healthcare providers prescribe it off-label for obesity, Ozempic is not FDA -approved for weight loss.

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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. Ozempic is not approved by the FDA for weight loss. Is Ozempic approved for weight loss?

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The Checkup by Singlecare

DECEMBER 6, 2024

Because clonidine works differently than other blood pressure medications, it also has several off-label uses including anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), and alcohol withdrawal. When taken together, the risk of these adverse events can increase. In addition, alcohol can increase your blood pressure.

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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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pharmaphorum

AUGUST 24, 2020

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. . Project Patient Voice .

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Labelling Communication FDA 128

Pharmacy Times

JULY 11, 2023

The updated label for inclisiran (Leqvio) includes patients with comorbidities, such as hypertension and diabetes, who have yet to experience a cardiovascular event.

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European Pharmaceutical Review

MARCH 6, 2024

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.

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STAT

OCTOBER 25, 2022

Food and Drug Administration regulate drugs, including approved uses and claims made by ads and product labels. Meanwhile, states regulate the actual prescribing events — providers, pharmacies, and medical practice standards. Federal agencies like the U.S. Continue to STAT+ to read the full story…

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The Checkup by Singlecare

DECEMBER 12, 2024

In fact, the Food and Drug Administration (FDA) says consumers should exercise a lot of caution when considering using a compounded drug. Ozempic is arguably the most popular semaglutide drug, not because of its FDA-approved use for treating Type 2 diabetes but because of the amount of weight people have lost while taking it.

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The Checkup by Singlecare

MARCH 20, 2025

The degree of risk of these bleeding events is dependent on an individuals risk factors such as age and frequency of falls. per year Allergic reaction Yes Less than 1% Yes 1%2% Reyes syndrome No N/A Yes Rare Sources: DailyMed Eliquis drug label , StatPearls , and AVERROES trial. per year Yes 3.8%

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The Checkup by Singlecare

JANUARY 6, 2025

Besides simply lowering LDL, the drug is approved by the Food and Drug Administration (FDA) for reducing the risk of cardiovascular events like heart attacks. Preventing cardiovascular events, such as heart attacks or strokes, from happening or recurring is another salient goal for cholesterol medication.

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The Checkup by Singlecare

NOVEMBER 5, 2024

Because they have different approved indications from the Food and Drug Administration (FDA) and off-label uses , Eliquis and Plavix are not considered competitors. Because they have different approved indications from the Food and Drug Administration (FDA) and off-label uses , Eliquis and Plavix are not considered competitors.

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The Checkup by Singlecare

OCTOBER 4, 2023

That’s why you may have seen people talk about a medication called Vyvanse, which is FDA approved to treat ADHD and binge eating disorder, as a good option for weight loss. In 2015, the FDA approved Vyvanse to be used in the treatment of binge eating disorder. Does Vyvanse cause weight loss?

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The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Some insurance plans may cover Ozempic for managing Type 2 diabetes , which is an indication that is approved by the Food and Drug Administration (FDA) to treat. Does insurance cover compounded semaglutide?

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The FDA Law Blog

JANUARY 2, 2023

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. Labeling in the drug and biologics approval process.

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Digital Pharmacist

OCTOBER 24, 2022

The FDA protects public health by ensuring the efficacy and safety of human and veterinary drugs, including biological products and medical devices. It is critical for the FDA to continue to develop new advances in therapies to aid our communities in order to achieve better lives through better health. Date of Approval: 9/30/2022.

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The Checkup by Singlecare

FEBRUARY 17, 2025

Its not safe or effective, according to the Food and Drug Administration (FDA), and it may lead to serious health problems. Although these medications are effective, the FDA has not yet approved generic versions, meaning people can only get a prescription for semaglutide under its brand name. Is compounded semaglutide safe?

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STAT

SEPTEMBER 13, 2024

We plan to catch up on sundry tasks, promenade with the official mascots and escort Mrs. Pharmalot to an event or two. One doctor said he thinks the company wants to discourage using the drugs for unapproved purposes, a practice called off-label prescribing, which is legal and accepted in American medicine. And what about you?

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The FDA Law Blog

JULY 7, 2024

Unfortunately, the guidance for small entities recently published by FDA is little more than a summary digest of the multi-hundred-page final rule. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

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pharmaphorum

FEBRUARY 23, 2021

The FDA is to begin a fast review of Incyte’s Jakafi (ruxolitinib) for patients with chronic graft-versus-host disease (GVHD), which cannot be treated with steroids. No new safety signals were observed and adverse events were consistent with the known safety profile of Jakafi. FFS was not reached in the Jakafi group compared with 5.7

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The Checkup by Singlecare

DECEMBER 30, 2024

Regarding the additional utility, telmisartan and losartan have different approved uses from the Food and Drug Administration (FDA). Conversely, telmisartan has approval for cardiovascular event risk reduction in patients who are at least 55 years old and at high risk of cardiovascular events. What is losartan?

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The Checkup by Singlecare

NOVEMBER 15, 2024

Additionally, the FDA hasn’t listed any known interactions for the medications on the losartan or amlodipine labels. However, other possible adverse events include palpitations, flushing, fatigue, dizziness, nausea, stomach pain, skin rash, itching, and muscle cramps.

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PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. in the rituximab Rituximab is used to treat AAV, RA, and SLE on the label, systemic sclerosis, inflammatory myopathies, Sjogren syndrome, and IgG4-related disease off label 10. Infections were observed in 33.9%

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pharmaphorum

SEPTEMBER 2, 2021

The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. The post FDA firms up JAK inhibitor warnings after Xeljanz review appeared first on.

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Pharma Marketing Network

MARCH 27, 2025

Brands tiptoed around platforms like Facebook or Twitter, fearful of FDA repercussions, adverse event reporting, and lack of clear guidance. While off-label promotion is still strictly regulated, unbranded awareness campaigns have found creative footing. Compliance, AI, and the Balancing Act Compliance remains a key concern.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The company’s NDA was supported mainly by the data obtained from the Phase I clinical trial completed in June 2021, and the Phase III ASCEND trial.

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pharmaphorum

AUGUST 9, 2021

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. In 2010, Lumizyme’s label was expanded to the under-right group as well.

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The FDA Law Blog

NOVEMBER 13, 2023

Designed for in-house legal and compliance counsel, industry executives, and private practice attorneys working for the OTC drug industry, the event will welcome distinguished industry thought leaders – including from the National Advertising Division and FDA – to share their expertise and strategic insights. Director Deborah L.

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