Drug Patent Watch

FEBRUARY 17, 2025

Step 2: ANDA Filing Generic drug manufacturers submit an Abbreviated New Drug Application (ANDA) to the FDA, which includes detailed information about the proposed generic drug, including its active ingredients, dosage forms, and manufacturing processes. This includes providing clear instructions for use, warnings, and precautions.

Packaging

Pharmacy Times

AUGUST 7, 2025

Labels now emphasize the risks of higher doses and caution against abrupt discontinuation in dependent patients to prevent withdrawal and other harms. SHOW MORE The FDA intends to update opioid labels to highlight risks of addiction, overdose, and interactions, enhancing safety in pain management practices.

Labelling

Pharmacy Times

JUNE 27, 2025

Although no formal contraindications are listed in AstraZeneca’s US labeling, perioperative management may require holding acalabrutinib 3 to 7 days before and after surgery to minimize bleeding risk. Hepatotoxicity and drug-induced liver injury are additional risks that require monitoring. Subscribe Now!

Pharmacy Technician

PharmExec

AUGUST 1, 2025

This demonstrated Vizz’s ability to improve near sighted vison within 30 minutes of dosage, with an active timeframe upwards of 10 hours. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.

Labelling

PharmExec

AUGUST 1, 2025

New labels will include study summaries, improved dosage warnings, and information on overdose reversal agents to enhance patient and healthcare professional awareness. Label changes aim to promote safer, research-supported decision-making, with a 30-day window for industry recipients to submit updates for review.

Medication Labelling

Pharmacy Times

JUNE 23, 2025

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies.

Pharmacy Technician

Pharmacy Times

JULY 10, 2025

2 Guiding prescribers and patients through initiation of lumatperone, adjusting dosage amounts, and switching from other antipsychotics, emphasizing its favorable relapse reduction profile is key in preventing relapse. 1-3 REFERENCES 1. Johnson & Johnson. Journal of Medical Economics, 16 (11), 1290–1299. Subscribe Now!

Pharmacy Technician

Pharmacy Times

JULY 22, 2025

By incorporating a patient's genetic profile into therapeutic decision-making, pharmacists can identify optimal drug choices and dosages while minimizing the risk of adverse events (AEs). Developed in partnership with InterSystems, the platform uses proprietary algorithms to personalize drug selection and dosage.

Pharmacy Technician

Pharmacy Times

JULY 17, 2025

Despite observational evidence, causation is not established, necessitating further research on dosage effects and neurocognitive outcomes. The inconsistency underscores the need for further research, particularly prospective studies that control for dosage and assess neurocognitive outcomes over time.

Pharmacy Technician

Pharmacy Times

JUNE 20, 2025

There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Oncology pharmacy practice changes at a rapid pace. Fifteen years ago, pharmacists could learn oncology on the job. Subscribe Now!

Pharmacy Technician

Pharmaceutical Technology

JUNE 27, 2025

June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.

Labelling

Pharmacy Times

JULY 7, 2025

Limitations included open-label design and dosage constraints, but the multicountry approach enhanced generalizability and external validity. All patients underwent a 20-week correction period for dosage titration and Hb correction, which was followed by an 8-week evaluation for efficacy assessments. 1 REFERENCES 1.

Pharmacy Technician

PharmaTech

AUGUST 1, 2025

Required labeling updates include clearer risk information, stronger warnings, and guidance on opioid use, with a 30-day submission deadline for manufacturers. SHOW MORE The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

Medication Labelling

PharmaTech

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). In addition, many patients are hesitant to receive eye injections.

Dosage

Pharmacy Times

JUNE 30, 2025

2,3 LIMBER is a phase 1, open-label, dose escalation study evaluating INCB057643 as a monotherapy at a dose escalation of 4 to 12 mg daily (part 1) or in combination with ruxolitinib at a dosage of 4 mg once daily and escalating to the maximum tolerated dose in part 1 (part 2). 2025 ASCO Annual Meeting. May 30, 2025, to June 3, 2025.

Pharmacy Technician

PharmaTech

JUNE 25, 2025

Information on how to register for the free webinars can be found on EDQM’s website. License information for the new digital edition is also available at the site. Thakar ; Varanya Chaiyaperm June 23rd 2025 Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

Dosage

Pharmaceutical Commerce

JULY 16, 2025

Compounding, by definition, involves customizing medications to meet individual patient needs, such as altering dosage forms or removing allergens. This all leads to an increased risk of adverse events, like contamination, incorrect dosages, or unexpected side effects, simply because production can vary wildly.

Compounding

PharmaTech

JUNE 26, 2025

Thakar ; Varanya Chaiyaperm June 23rd 2025 Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Thakar ; Varanya Chaiyaperm June 23rd 2025 Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

Dosage

PharmaTech

JULY 17, 2025

Stage 1: design the compounding blueprint Establish a complete plan including ingredients, packaging, calculations, labeling, and patient-specific factors. Stage 3: dosage form completion & quality evaluation Conduct rigorous physical and analytical testing; 503B batches must meet GMP-level standards. antineoplastics, allergens).

Compounding

Pharmacy Times

JULY 30, 2025

3 Gedatolisib’s efficacy and safety were demonstrated in the phase 3, open-label, randomized VIKTORIA-1 trial evaluating gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Pharmacy Technician

Pharmaceutical Technology

AUGUST 14, 2025

The anticipated launch of APT-1011, an ODT formulation of fluticasone propionate, will add further choice for patients, particularly in paediatrics where dosage form is a major factor in adherence. The eosinophilic oesophagitis (EoE) market in the US is forecast to grow from $202 million in 2020 to $1.19

Insurance Coverage and Processing

The Pharmacist

JULY 10, 2023

A batch of Labetalol 200mg tablets has been recalled as they are incorrectly labelled as 100mg tablets on the foil blister packaging. But the Medicines Healthcare Products Regulatory Agency (MHRA) said that the actual tablets were 200g strength, consistent with the information on the outside of the box.

Dosage

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

Labelling

RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

Labelling

FADIC

JULY 14, 2024

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. Here are some resources that can provide you with the best information on OTC drugs. Link National Institutes of Health (NIH) The NIH is a part of the U.S.

Adverse Reactions

FDA Law Blog: Biosimilars

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

Labelling

Express Pharma

APRIL 6, 2023

This can include everything from product testing and labelling to marketing and advertising requirements. As a result, nutraceutical startups need to stay informed about the latest regulatory changes and requirements in the states where they do business. Failure to do so can lead to legal and financial consequences.

Labelling

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

Labelling

PharmaTech

JANUARY 16, 2023

The guidance provides examples of required and recommended information in the Dosage and Administration section.

Labelling

pharmaphorum

AUGUST 11, 2022

These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up. Looking at an individual’s genomic profile also provides an understanding of appropriate medication dosage. billion in the United States alone.

Dosage

FADIC

OCTOBER 20, 2023

People can follow the “Drug Facts Label” directions on OTC products for proper use. Pharmacists can provide patients with the necessary information to make proper selections when choosing OTC products. This personalized approach allows them to gather detailed information about a patient’s condition.

Health and Personal Care Stores

Express Pharma

JUNE 2, 2023

Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all. These systems enable real-time monitoring, accurate data capture, and seamless integration of information across various stakeholders, from manufacturers to healthcare providers.

Adverse Reactions

RX Note

MARCH 18, 2023

It is a quick reference for indication, dosage, availability and prescribing category. For drugs not available in MOHMF , a separate drug list (with specific indication and dosage information) should be created so that individual facility can activate the medicines into hospital formulary if needed.

Hospitals

RX Note

NOVEMBER 12, 2024

It supports informed, evidence-based clinical decision-making, drug supply chain management and patient education. Features The new Micromedex mobile app provides unified access to all essential drug information from a single, comprehensive app. Hence, there would be no significant difference in the information offered.

Dosage

FADIC

OCTOBER 24, 2023

The application includes submitting clinical drug trial data and information about the manufacturing process. Drug manufacturers also have to submit details about how the drug works in the human body, guidelines for dosage, and information on safety and side effects. This information is included in the prescription.

Health and Personal Care Stores

European Pharmaceutical Review

OCTOBER 5, 2022

Beyond the risk of accidental ingestion, there are also health requirements surrounding ingredient profiles and the safe administering of medicines, including dosages and product accessibility. Reaching for the renewable. Pharmaceutical packaging firms are currently researching bio-based and renewable materials.

Packaging

The Thyroid Pharmacist

AUGUST 23, 2023

Please note: Some people may need to increase their dosage of thiamine from 600 mg per day. It looked at the effect of thiamine on patients with Crohn’s disease and ulcerative colitis, and found that effective dosages ranged from 600 mg to 1,500 per day, depending on individual body size. [7] Have you tried thiamine?

Dosage