2022, FDA and Labelling - Pharmacy Technician Pulse

Help Turn Occasional Shoppers into Loyal Customers by Investing in the Front End

Drug Topics

JULY 10, 2025

Private-Label Partnerships can Streamline Operations and Enhance the Customer Experience Offering a broad selection of private-label OTC products can help your pharmacy stay competitive and support your customers’ evolving needs. Private-label brands allow you to deliver the same quality as larger name brands, often at a lower cost.

Health and Personal Care Stores

Health and Personal Care Stores Independent Pharmacies Labelling Specialty Pharmacies

Five Interesting Things To Know About Sulopenem (Orlynvah)

IDStewardship

JANUARY 13, 2025

In case you are wondering, the FDA label does not list any hepatic dose adjustments. 2022 Apr;82(5):533-557. The absence of renal dose adjustments may be attributed to sulopenem dual excretion pathways, with elimination occurring through both feces and urine. Chicago, IL: Iterum Therapeutics; 2024. Zhanel GG, et al.

Packaging

Packaging Labelling FDA

Do semaglutide tablets work?

The Checkup by Singlecare

MARCH 11, 2025

Drug manufacturer Novo Nordisk produces it under the brand name Rybelsus , and the FDA approved it for managing blood glucose in people with Type 2 diabetes but not Type 1 diabetes. Some healthcare providers might prescribe it off-label for weight management as well. mg dose once weekly. over 104 weeks, compared to 2.6% at 12 months.

Compounding

Compounding Compounding Pharmacies FDA Dosage

Mounjaro generic availability, cost, and more

The Checkup by Singlecare

APRIL 15, 2025

Mounjaro (tirzepatide) is a brand-name prescription medication that is approved by the Food and Drug Administration (FDA) to improve blood sugar levels in people with Type 2 diabetes. The FDA recently approved generic versions of two other GLP-1s , Victoza (liraglutide) and Byetta (exenatide). Is there a generic for Mounjaro?

Compounding

Compounding Dosage Compounding Pharmacies FDA

Gabapentin side effects in men

The Checkup by Singlecare

APRIL 18, 2025

In fact, its kind of a jack-of-all-trades drug, approved by the Food and Drug Administration (FDA) to treat epilepsy, postherpetic neuralgia, and restless leg syndrome. Its also prescribed off-label for other types of nerve pain, diabetic neuropathy, mood disorders, and alcohol use disorder.

Adverse Reactions

Adverse Reactions Controlled Substances Labelling Dosage

Five Things For Pharmacists To Know About The Treatment Of Mycobacterium Tuberculosis

IDStewardship

JUNE 19, 2025

In 2014, the US FDA approved this regimen, and it features in the latest WHO guidelines for LTBI treatment. Her postgraduate education includes an MSc in Pharmacy Practice, which focuses on unintended consequences of spurious penicillin allergy labels, non-medical independent prescribing, and a healthcare leadership fellowship.

HIV Treatment and Prevention Agents

HIV Treatment and Prevention Agents Adverse Reactions Dosage Labelling

Final Rule for ACNU Arrives in Time for End of Year but Not Much New to Celebrate

The FDA Law Blog

JANUARY 5, 2025

Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. 105288 (Dec.

Labelling

Labelling FDA

Can Ozempic cause heart palpitations?

The Checkup by Singlecare

MARCH 31, 2025

Ozempic is the brand name for semaglutide, which is a medication thats FDA approved to treat high blood sugar in people with Type 2 diabetes. It is also often prescribed off-label as a weight loss medication, even in patients with normal blood sugars.

Dosage

Dosage Labelling Hospitals FDA

ICH Q6B for Analytics

PharmTech

JUNE 6, 2025

In these instances, gas phase sequencing of purified peptides (also known as Edman sequencing) can be performed to sequentially identify amino acids based on their chromatographic elution positions following specific, sequential chemical labeling. 2022 11, 41-44 Greer, F and Easton, R.L. Mordorintelligence.com (accessed May 5, 2025).

Dosage

Dosage Documentation Labelling FDA

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

JUNE 23, 2025

The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.

FDA

FDA Compounding Pharmacies Dosage Hospitals

Advanced Solutions for Sustained Delivery of Ocular Therapies

PharmTech

JULY 4, 2025

While treatments for infection, inflammation, high eye pressure, and neovascularization have been shown to be effective, this method of delivery is considered “off-label,” as FDA has not approved products specifically for this use, except two intracameral implants (see below). Press Release, March 2, 2022. Punctal Plugs.

Dosage

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Mounjaro statistics 2025

The Checkup by Singlecare

JUNE 25, 2025

Due to Ozempic’s newsworthy shortages and a growing demand for more GLP-1 drugs, people started talking about Mounjaro in 2022, when it was approved by the Food and Drug Administration (FDA) for the treatment of Type 2 diabetes. Mounjaro was approved by the FDA in 2022 for the treatment of Type 2 diabetes.

Insurance

Insurance Dosage FDA Labelling

Insurance stopped covering my GLP-1: What to do next

The Checkup by Singlecare

JULY 15, 2025

The Food and Drug Administration (FDA) may no longer approve the drug based on new safety evidence. Changes in GLP-1 insurance coverage may be due to the rising costs to health plans of the medication and the recent FDA approval of generic versions of Victoza ( liraglutide ) and Byetta ( exenatide ). Contact your insurance company.

Insurance

Insurance Insurance Coverage Documentation Health Insurance Companies

Pharmacy Focus: Importance of Mental Health for Patients and Pharmacists Alike

Pharmacy Times

JULY 10, 2025

Medication Adherence Requires Personalized Communication Alva emphasized that effective counseling about medications—especially those with intimidating FDA warnings—requires compassionate, patient-centered communication.

Specialty Pharmacies

Specialty Pharmacies Vaccines Immunization Compounding Pharmacies

ADA 2025: Advances in Type 2 Diabetes Management With Tirzepatide

Pharmacy Times

JUNE 23, 2025

1 Image credit: Cynthia | stock.adobe.com The discussion featured Vivian Fonseca, MD, of the Tulane University School of Medicine, who presented an overview of tirzepatide based on the FDA-approved label and clinical guidelines. FDA Approves Tirzepatide Injection for Adults With Type 2 Diabetes. May 16, 2022.

HIV Treatment and Prevention Agents

HIV Treatment and Prevention Agents Compounding Pharmacies Immunization FDA

Ropeginterferon Alfa 2b Is Well-Tolerated, Efficacious in Treatment of Prefibrotic Myelofibrosis

Pharmacy Times

JUNE 30, 2025

2-5 In the multicenter, phase 2, open-label prospective study, researchers investigated ropeg-IFN-α2b treatment in patients with profibrotic MF or DIPSS low-intermediate-1 risk MF. Updated October 6, 2022. FDA approves ropeginterferon alfa-2b-njft for polycythemia vera. REFERENCES 1. Accessed June 30, 2025. Pharmacy Times.

Compounding Pharmacies

Compounding Pharmacies Immunization Compounding Hospitals

Mitomycin Intravesical Solution Receives FDA Approval for Non-Muscle Invasive Bladder Cancer

Pharmacy Times

JUNE 12, 2025

Mitomycin intravesical solution (Zusduri, UroGen Pharma) was approved by the FDA for treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). November 16, 2022. A fatal adverse reaction of cardiac failure occurred in 1 patient. Front Oncol. doi:10.3389/fonc.2022.1044830

FDA

FDA Compounding Pharmacies Vaccines Immunization

Wegovy facts and statistics 2025

The Checkup by Singlecare

JUNE 25, 2025

In 2021, the Food and Drug Administration (FDA) approved Wegovy for weight loss in adults with obesity—or who are overweight with at least one weight-related health condition. In 2022, the approval was expanded to include eligible individuals 12 years and older with obesity. Of those, 34% were adult males and 28% were adult females.

Insurance Coverage

Insurance Coverage Insurance FDA Labelling

FDA Posts Slate of Seven Warning Letters Following Company Inspections

PharmTech

JUNE 12, 2025

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). American Behavioral Research Institute Boca Raton, Fla. – Amish Origins Management Worland, Wy. –

FDA

FDA Dosage Compounding Labelling

Is ther fentanyl in an epidural?

The Checkup by Singlecare

MAY 6, 2025

Fentanyl used in healthcare settings is overseen by the FDA. According to its drug label, bupivacaine reaches very low levels three to six hours after administration. Read on to learn more about the use of fentanyl in epidurals, including safety considerations and how it works for pain management. What is fentanyl used for?

Hospitals

Hospitals Labelling FDA

Fentanyl facts and statistics

The Checkup by Singlecare

MAY 6, 2025

It can be prescribed off-label for certain types of pain, especially severe acute pain or pain caused by cancer. Fentanyl may also be prescribed off-label, meaning for a purpose other than what the Food and Drug Administration (FDA) approved it for. SAMHSA, 2024) In 2022, only 1 in 4 U.S. As of Sept.

Labelling

Labelling Dosage Packaging FDA

Does Wegovy cause anxiety?

The Checkup by Singlecare

JULY 3, 2025

Wegovy (semaglutide) is a prescription medication that’s approved by the Food and Drug Administration (FDA) to help with weight management in people ages 12 years and older with obesity and in adults who are overweight with at least one weight-related comorbid condition.

Insurance

Insurance Packaging FDA Labelling

ADHD drugs back in the spotlight after study debunks rising prevalence

Pharmaceutical Technology

JUNE 6, 2025

In 2022, Axsome paid $53m up front to acquire Sunosi from Jazz Pharmaceuticals. Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. Sunosi is already approved in the UK to treat excessive daytime sleepiness (EDS) in adults with narcolepsy, with or without cataplexy.

Communication

Communication Hospitals Packaging Labelling

Wegovy vs. Mounjaro for weight loss

The Checkup by Singlecare

JUNE 6, 2025

Although the Food and Drug Administration (FDA) has approved them for different uses, they’re commonly used as weight loss drugs. Note that compounded semaglutide and compounded tirzepatide products are not FDA approved.) While these drugs are commonly prescribed for weight loss, they do not have the exact same FDA-approved uses.

Insurance

Insurance FDA Labelling Dosage

How much does semaglutide cost per month?

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?

Compounding

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LEO Pharma secures rights to Boehringer’s Spevigo for $105m

Pharmaceutical Technology

JULY 15, 2025

Comparing sales from other drugs is tricky because Spevigo is the only US Food and Drug Administration (FDA)-approved treatment specifically for GPP. Christophe Bourdon, who was appointed CEO in 2022 and tasked with turning the fortunes of the company around, has made no secret of public listing plans.

Packaging

Packaging Communication Hospitals Vaccines

Mounjaro vs. Ozempic for weight loss

The Checkup by Singlecare

JUNE 6, 2025

However, the Food and Drug Administration (FDA) has approved Ozempic for additional indications that Mounjaro hasn’t been approved for. While Mounjaro and Ozempic have some similarities, they are not exactly the same, especially when it comes to weight loss, which is an indication that’s not approved by the FDA but is a common off-label use.

Insurance

Insurance Labelling FDA Insurance Coverage

From data to impact: How real-world evidence will transform healthcare

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 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 & (..)

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies Documentation Labelling

FDA’s New Priority Voucher Pilot Program Has Landed: CNPV

The FDA Law Blog

JUNE 18, 2025

Livornese — After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews. Tobolowsky & Michelle L. Butler & Deborah L.

FDA

FDA Communication Labelling

Why security-first design is the fix to stalling AI pilot tools

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 & (..)

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies FDA Labelling

Moderna shines spotlight on new flu vaccine data

pharmaphorum

JUNE 30, 2025

Skip to main content Monday 30 June 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 & (..)

Vaccines

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA

FDA blesses atopic dermatitis label expansions for Organon's Vtama, Galderma's Nemluvio

Fierce Pharma

DECEMBER 16, 2024

The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD). | The FDA has blessed two previously approved medicinesone a cream and the other an injectionto treat atopic dermatitis (AD).

Labelling

Labelling FDA

AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression

Fierce Pharma

DECEMBER 19, 2022

AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression. Mon, 12/19/2022 - 11:13.

Labelling

Labelling FDA

Off-label treatment for alcohol use disorder is linked to slower liver decline, study suggests

STAT

MAY 22, 2024

WASHINGTON — There are three FDA-approved drugs for treating alcohol use disorder. But a different medication, one frequently used off-label for the condition, could provide greater benefit to patients with alcohol-associated liver disease, a new study suggests. Read the rest…

Labelling

Labelling FDA

FDA releases analysis on drug product quality in 2022

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

FDA

FDA Labelling

FDA approves long-acting injectable for schizophrenia and bipolar disorder

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. According to 2022 data gathered by the World Health Organization (WHO), there are around 24 million schizophrenia patients. Clinical trials of the FDA approved Rykindo ®.

FDA

FDA Labelling

FDA Approvals: September 2022 Recap

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.

FDA

FDA Adverse Reactions Pharmaceutical Companies Pharmaceutical Companies

FDA approves Zepbound for weight loss

The Checkup by Singlecare

NOVEMBER 9, 2023

Food and Drug Administration (FDA) just approved Zepbound (tirzepatide) for chronic weight management. The injectable medication is a new version of Eli Lilly’s Mounjaro, which is approved by the FDA to control blood sugar in people with Type 2 diabetes. Zepbound, on the other hand, has been FDA-approved for weight loss.

FDA

FDA Labelling Insurance

RFID: The future of smart labelling?

Pharmaceutical Technology

MARCH 22, 2023

The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format. In the US Drug Quality and Security Act (DSCSA), the FDA mandates that manufacturers and trading partners should have full interoperable electronic track and trace systems in place by November 2023.

Labelling

Labelling Data Entry Communication FDA

Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine

The FDA Law Blog

DECEMBER 22, 2022

Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost. Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) passed without those sections.

FDA

FDA Labelling

FDA Finalizes Guidance Re Enforcement Policy for Homeopathic Drugs

The FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. FDA denied that petition in 2019.

FDA

FDA Labelling

Health Canada expands Orkambi label to include access to infants

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.

Labelling

Labelling Communication FDA

The 50 most-filled prescriptions of 2022

The Checkup by Singlecare

DECEMBER 8, 2022

Here’s a look at the 50 most-filled prescriptions of 2022. 50 most prescribed drugs of 2022. 1, 2022 through Oct. 31, 2022, excluding opioids and weight-loss drugs. Read on to learn more about the top 10 drugs of 2022. . It’s also frequently prescribed as an off-label treatment for fibromyalgia.” .

Dosage

Dosage Controlled Substances Labelling Immunization

Opinion: Four types of bias in medical AI are running under the FDA’s radar

STAT

JANUARY 9, 2023

Although artificial intelligence is entering health care with great promise, clinical AI tools are prone to bias and real-world underperformance from inception to deployment, including the stages of dataset acquisition, labeling or annotating, algorithm training, and validation.

Labelling

Labelling FDA

Help Turn Occasional Shoppers into Loyal Customers by Investing in the Front End

Five Interesting Things To Know About Sulopenem (Orlynvah)

Trending Sources

Do semaglutide tablets work?

Mounjaro generic availability, cost, and more

Gabapentin side effects in men

Five Things For Pharmacists To Know About The Treatment Of Mycobacterium Tuberculosis

Final Rule for ACNU Arrives in Time for End of Year but Not Much New to Celebrate

Can Ozempic cause heart palpitations?

ICH Q6B for Analytics

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Advanced Solutions for Sustained Delivery of Ocular Therapies

Mounjaro statistics 2025

Insurance stopped covering my GLP-1: What to do next

Pharmacy Focus: Importance of Mental Health for Patients and Pharmacists Alike

ADA 2025: Advances in Type 2 Diabetes Management With Tirzepatide

Ropeginterferon Alfa 2b Is Well-Tolerated, Efficacious in Treatment of Prefibrotic Myelofibrosis

Mitomycin Intravesical Solution Receives FDA Approval for Non-Muscle Invasive Bladder Cancer

Wegovy facts and statistics 2025

FDA Posts Slate of Seven Warning Letters Following Company Inspections

Is ther fentanyl in an epidural?

Fentanyl facts and statistics

Does Wegovy cause anxiety?

ADHD drugs back in the spotlight after study debunks rising prevalence

Wegovy vs. Mounjaro for weight loss

How much does semaglutide cost per month?

LEO Pharma secures rights to Boehringer’s Spevigo for $105m

Mounjaro vs. Ozempic for weight loss

From data to impact: How real-world evidence will transform healthcare

FDA’s New Priority Voucher Pilot Program Has Landed: CNPV

Why security-first design is the fix to stalling AI pilot tools

Moderna shines spotlight on new flu vaccine data

FDA blesses atopic dermatitis label expansions for Organon's Vtama, Galderma's Nemluvio

AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression

Off-label treatment for alcohol use disorder is linked to slower liver decline, study suggests

FDA releases analysis on drug product quality in 2022

FDA approves long-acting injectable for schizophrenia and bipolar disorder

FDA Approvals: September 2022 Recap

FDA approves Zepbound for weight loss

RFID: The future of smart labelling?

Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine

FDA Finalizes Guidance Re Enforcement Policy for Homeopathic Drugs

Health Canada expands Orkambi label to include access to infants

The 50 most-filled prescriptions of 2022

Opinion: Four types of bias in medical AI are running under the FDA’s radar

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