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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Pharma Marketing Network

JULY 2, 2025

In the digital-first era, social media marketing strategies are reshaping how pharmaceutical companies engage with healthcare professionals, patients, and caregivers. However, every claim must be backed by science and formatted according to FDA and FTC guidelines. Can pharma companies use paid social ads?

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Digital Pharmacist

OCTOBER 24, 2022

CDER relies on its understanding of science and regulatory procedures to support and provide advice to pharmaceutical companies in testing and manufacturing, to then bring these new therapies to the market to aid patients and their health. The FDA granted the approval of Relyvrio to Amylyx Pharmaceuticals Inc.

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Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. A decision from the FDA is possible for later this year, with Lilly currently finalizing an application for fast-track approval.

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Pharma Marketing Network

MARCH 18, 2025

Brand Authority: By appearing at the top of search engine results, pharmaceutical companies increase brand credibility among HCPs. Use a mix of: Branded Keywords: Drug names, pharmaceutical companies, or treatment-specific terms. Avoiding misleading claims or unapproved off-label promotions.

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The Checkup by Singlecare

DECEMBER 12, 2024

Ozempic is also sometimes prescribed off-label (for a non-FDA-approved use) as a weight loss drug. An overview of semaglutide Novo Nordisk, the pharmaceutical company that manufactures FDA-approved semaglutide products, currently manufactures three medicines that contain semaglutide.

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European Pharmaceutical Review

OCTOBER 24, 2022

However until now, prescribing a treatment for children with ADHD has been off-label or unlicensed in the UK. AGB-Pharma , the Swedish pharmaceutical company that produced the drug, predicted around 60 percent of all melatonin prescriptions are dispensed to under 18s off-label or unlicensed.

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The Checkup by Singlecare

FEBRUARY 14, 2024

One such medication is Mounjaro (tirzepatide), a GLP-1 receptor agonist manufactured by the pharmaceutical company Eli Lilly. That’s why even though the medication is only approved by the Food and Drug Administration (FDA) for Type 2 diabetes, it’s also used off-label as a weight-loss medication. of their body weight.

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The Checkup by Singlecare

SEPTEMBER 26, 2024

Although both medications are FDA approved to treat Type 2 diabetes , they differ in many ways. Mounjaro is a brand-name medication manufactured by Eli Lilly and Company. Metformin is a generic drug manufactured by various pharmaceutical companies. Mounjaro is an FDA-approved medication for managing Type 2 diabetes.

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The Checkup by Singlecare

APRIL 17, 2025

Saxenda ( liraglutide ) is a brand-name glucagon-like peptide-1 ( GLP-1 ) agonist made by the pharmaceutical company Novo Nordisk. Food and Drug Administration (FDA) for chronic weight management in adults with a starting, or baseline , body mass index ( BMI ) of 30 or more ( obesity ). It is approved by the U.S.

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The Checkup by Singlecare

FEBRUARY 7, 2023

Unlike copay cards , which are offered by pharmaceutical companies to offset the price of brand-name drugs for patients with commercial insurance, PAPs are intended for those who are uninsured or underinsured and need financial assistance, explains Dr. Residency: Most PAPs are only available to patients who live in specific states or regions.

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The People's Pharmacy

JUNE 12, 2023

The parties that benefit are the pharmaceutical companies and the pharmacies. The losers are patients, insurance companies and the country as a whole for wasting money on unneeded things. If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. The FDA does virtually no testing.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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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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The Checkup by Singlecare

FEBRUARY 14, 2025

It is also commonly prescribed off-label (for non-FDA-approved use) to help with weight loss and weight management in people with obesity or who are overweight with weight-related medical conditions. So, what is compounded tirzepatide, and why is it made when there are already FDA-approved tirzepatide products available?

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pharmaphorum

JULY 2, 2025

Skip to main content Wednesday 2 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

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The Checkup by Singlecare

FEBRUARY 13, 2025

Eli Lilly and Company, the pharmaceutical company that manufactures FDA-approved tirzepatide products, currently makes two medicines that contain tirzepatide. There are no FDA-approved generic versions of these two drugs, and there are no other FDA-approved tirzepatide products.

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Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. Since then, ketamine-assisted psychotherapy has become increasingly prominent, and is often used off label to treat certain kinds of depression. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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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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The Checkup by Singlecare

APRIL 30, 2024

Ozempic is one of three medications approved by the Food and Drug Administration (FDA) with the active ingredient semaglutide. Currently, Ozempic is FDA-approved for adults with Type 2 diabetes. Ozempic is made by the pharmaceutical company Novo Nordisk. Ozempic is a type of medication that needs to be injected.

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Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. as the secondary endpoints. as the secondary endpoints.

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The Checkup by Singlecare

FEBRUARY 13, 2025

It was approved by the Food and Drug Administration (FDA) in 2022 to help control blood sugar levels in adults with Type 2 diabetes , but healthcare providers often prescribe this medicine off-label (for a non-FDA-approved use) for weight loss in people with obesity (or overweight with certain medical conditions).

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Impact Pharmaceutical Services

AUGUST 9, 2022

IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009. Even though this company has a Regulatory Affairs Department, their rapid growth over the years has made “in-sourcing” of help a necessity. Regulatory Affairs Strategy and Project Team Lead.

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Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing.

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The Checkup by Singlecare

AUGUST 29, 2023

Food and Drug Administration (FDA) in 2012 as a brand-name drug. The FDA approved two applications for generic versions of Eliquis by the companies Micro Labs Limited and Mylan Pharmaceuticals, Inc. mg or 5 mg tablets of Eliquis Free coupons Eliquis coupons What are the off-label uses for Eliquis?

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The Checkup by Singlecare

APRIL 5, 2024

Health condition Insurance companies are much more likely to cover Ozempic when it’s prescribed for diabetes than for weight loss. That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment.

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Pharma Marketing Network

MAY 14, 2025

For pharmaceutical companies, this means delivering tailored messages to specific audiencessuch as HCPs, patients, or caregiversbased on data like browsing behavior, demographics, and professional credentials. This includes safeguarding patient data and avoiding off-label promotion.

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BuzzRx

OCTOBER 14, 2022

Commercially Unavailable Medications Some medications are not profitable enough for large pharmaceutical companies to make. Off-Label Medication Use Sometimes healthcare providers prescribe an FDA-approved medication to treat a condition for which it is not FDA-approved.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. She has worked with regulatory agencies and pharmaceutical companies for over 10 years. Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry Draft Guidance.

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pharmaphorum

APRIL 15, 2021

In the US, for example, the FDA now provides the opportunity for initial target engagements for regulatory advice, known as ‘INTERACT meetings’. Astellas’ regulatory affairs function plays a key role in helping to define the final target indication of the therapy, or broadening the target for the profile, or target product label. “In

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The Checkup by Singlecare

OCTOBER 10, 2023

With its FDA approval in 1997, Flomax has become a widely prescribed medication in the United States, particularly for older men more susceptible to BPH. Read the label or consult a pharmacist to verify the medication is correct. What are the off-label uses for Flomax?

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Pharmaceutical Technology

NOVEMBER 25, 2022

Pharmaceutical companies are looking to paediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. Cambrex, for example, has a track record of success in partnering with several pharmaceutical companies in the development and commercialisation of clinically suitable PDFs.

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The Checkup by Singlecare

JULY 2, 2024

But she emphasizes that out-of-pocket cost depends on the health plan—and that sometimes patients must try other medications before the insurance company will approve coverage of Aimovig. Amgen is one of such pharmaceutical companies.

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Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. The pilot scheme for this has been observed by the FDA and EU Commission.

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pharmaphorum

NOVEMBER 24, 2022

” Ganaplacide/lumefantrine has been awarded fast track and orphan drug status from the FDA. ” He continued: “The earlier we have new compounds and the faster the world adopts them, the better chance we stand of beating resistance.” Image by shammiknr from Pixabay .

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Viseven

NOVEMBER 17, 2022

They provide information about the following: Off-label usage Publications Safety information Independent medical education. Under its internal affairs, the pharmaceutical ones bring together the research and commercial wings of the pharma businesses. The role of medical affairs in pharmaceutical companies.

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