Big Molecule Watch

APRIL 29, 2025

The FDA disagreed with Regenerons proposal to add additional extended dosage intervals of greater than every 16 weeks, which is the maximum dosing interval on the currently approved label. For patients with diabetic retinopathy (DR), EYLEA HD is approved for 3 initial monthly dosages, with subsequent dosage intervals of 8-12 weeks.

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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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Labelling Biosimilars Adverse Reactions Dosage 49

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.

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Labelling Dosage Immunization Immunity 40

RX Note

MAY 8, 2025

Uses and off-label uses (with recommended dosage) Oral medication administration Advice to patients Essential points, including adverse drug reactions and role in therapy. Additionally, many registered products, including over-the-counter medications, supplements and drugs not listed in the MOHMF , are included. Now Available!

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Health and Personal Care Stores Dosage Community Pharmacies Labelling 52

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.

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Packaging Labelling Dosage Pharmaceutical Companies 52

Express Pharma

OCTOBER 20, 2024

The label provides a detailed indication. Diltiazem Hydrochloride Extended-Release Capsules USP in the 120 mg, 180 mg, and 240 mg dosages have an estimated market size of US$ 28.2 Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics.

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RX Note

JULY 7, 2025

It provides quick information on indications, dosage, availability and prescribing category. For drugs that are not available in the MOHMF , a separate drug list with detailed indication and dosage information should be created. Similarly, the off-label uses can be clearly highlighted too.

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Health and Personal Care Stores Formulary Information Hospitals Dosage 52

Pharmaceutical Technology

NOVEMBER 25, 2022

Pharmaceutical companies are looking to paediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. Various modifications to adult dosage forms (ADFs) are often needed to make a drug easier for children to take and easier for parents to administer. Innovative solutions to complex challenges.

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Dosage Pharmaceutical Companies Pharmaceutical Companies Packaging 52

European Pharmaceutical Review

NOVEMBER 1, 2024

Packaging types generating demand in the market include tamper-proofing drug packaging against counterfeiting, as well as single-dosage packaging, according to the research. Preparing for the impact of EU GMP Annex 1 on primary packaging Packaging types – what is driving the pharmaceutical container market?

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Packaging Dosage Labelling Pharmaceutical Companies 52

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.

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Labelling Packaging Documentation Dosage 52

Pharmaceutical Business Review

SEPTEMBER 22, 2023

The single dose escalation, open-label study intends to assess the pharmacodynamics and safety of KB408 in AATD adults with a PI*ZZ genotype. In the study, the efficacy, safety, and tolerability of three dosages of KB408 will be assessed in each cohort of three patients.

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Dosage Labelling 98

Express Pharma

MARCH 12, 2025

IPA also pointed out that US regulations require adverse events related to any dosage form of a drug to be reported under the same Abbreviated New Drug Application (ANDA) number, even if the product is manufactured at a different facility or outside India. Thus, it cannot be conclusively linked with the manufacturing site or manufacturers.

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Generic Medicine Process Improvement Dosage Pharmaceutical Manufacturing 63

European Pharmaceutical Review

NOVEMBER 30, 2022

The extension authorisation is based on an ongoing open-label, 24-week study ( NCT02881320 ), which indicated Biktarvy ® was effective and generally well-tolerated by virologically suppressed adolescents and children with HIV. After Week 48, participants could receive Biktarvy ® in an active open-label extension phase for up to 96 weeks.

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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.

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Labelling Biosimilars Drug Pricing Dosage 104

RX Note

JUNE 8, 2025

Australian Pharmaceutical Formulary and Handbook Similar to Australian Medicines Handbook , the Australian Pharmaceutical Formulary and Handbook (APF) provides dosage and counselling information, but it also provides several useful information chapters, such as Dispensing and labelling - Cautionary advisory labels recommendations for medicines Compounding (..)

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Compounding Hospitals Patient Counseling Labelling 40

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.

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Dosage Labelling 98

PharmaTech

JANUARY 16, 2023

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

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Labelling Dosage 40

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. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.

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Adverse Reactions Dosage Mayo Clinic Medical Schools 105

European Pharmaceutical Review

MARCH 6, 2024

As US-approved biosimilars, Wyost and Jubbonti have the same dosage form, route of administration, dosing regime and presentation as the Xgeva ® and Prolia ® , which are are registered trademarks of Amgen Inc. The approval is also accompanied by labelling with safety warnings.

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Biosimilars Dosage Labelling 98

Express Pharma

APRIL 6, 2023

This can include everything from product testing and labelling to marketing and advertising requirements. Challenge 4: Quality control and safety concerns Nutraceutical startups must ensure that their products meet quality and safety standards, as well as comply with labelling and advertising regulations.

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Labelling Dosage Packaging Documentation 98

European Pharmaceutical Review

AUGUST 17, 2022

The second facility for WuXi STA in the US, Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labelling, storage and distribution services for clinical trial materials and commercial drug products.

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Pharmaceutical Manufacturing Dosage Packaging Labelling 96

Pharmaceutical Technology

MARCH 29, 2023

Due to high demand, supply chain issues plagued access to Wegovy, with many physicians prescribing another version of semaglutide that is also produced by Novo Nordisk, Ozempic, on an off label basis. The ability to select either subcutaneous or oral dosage forms of VK2735 creates attractive potential treatment options,” he added.

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Diabetes Dosage Labelling 105

Pharmacy Joe

MARCH 7, 2024

Back in episode 473 , I talked about the evidence behind the discrepancy between the labeled dose and the analgesic ceiling dose of IV ketorolac. There is similar data on the ceiling dose of ibuprofen as well. 225 patients were split evenly between groups.

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Inpatient Dosage Labelling 98

European Pharmaceutical Review

NOVEMBER 25, 2022

If approved, paliperidone palmitate extended-release injectable suspension (LY03010) is primed as a favourable option to treat schizophrenia, due to reduced dosage requirement of a once-a-month, yet it risks being hidden in a crowded long-acting injectable (LAI) market, GlobalData warns.

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Dosage Labelling 105

Dr. Neal Smoller

MARCH 24, 2023

Topics Discussed Conditions and issues that CBD does help with Conditions and issues that CBD does not help with Clinical trial data on CBD’s positive effects How to read CBD product labels Proper CBD dosage Contaminants, like heavy metals, in CBD How to buy CBD without wasting money

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Dosage Labelling 52

Pharmaceutical Technology

OCTOBER 25, 2022

The dosage and schedule of the combination treatment is named the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab). Based on positive data from the open-label, international, randomised, multicentre Phase III HIMALAYA clinical trial, the regulatory agency granted the approval.

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Dosage Labelling Immunization Immunity 69

European Pharmaceutical Review

JANUARY 8, 2025

In the open-label portion of the CLEER-001 clinical trial of HT-001, 100 percent of cancer patients achieved the primary efficacy endpoint. What did the gel formulation trial find? Significant skin toxicity improvement was observed after six weeks, according to the data.

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Dosage Labelling 52

FADIC

OCTOBER 24, 2023

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. Labeling Labeling requirements also differ for prescription and OTC drugs. This way, a person can self-diagnose and treat their symptoms by reading the label.

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Health and Personal Care Stores Insurance Coverage and Processing Labelling Dosage 52

epicur

SEPTEMBER 13, 2023

This results in requests for precise dosages such as 1.22 However, the more closely we look at what it takes to compound an exact strength, the clearer it becomes standard dosages are more beneficial to both patients and veterinary practices. milligrams or other 0.1 Luckily, there is another option.

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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] J Altern Complement Med. doi: 10.1089/acm.2011.0840.

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Dosage Labelling 98

RX Note

JUNE 21, 2023

Dosage Co-trimoxazole comes in both double-strength and single-strength tablets. NOTE: Co-trimoxazole is also used off-label for primary prophylaxis of toxoplasma Gondii encephalitis in patients with HIV. Mechanism of Action Both trimethoprim and sulfonamides inhibit bacterial folate synthesis, but at a different step in the pathway.

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Dosage Labelling 52

FADIC

OCTOBER 20, 2023

People can follow the “Drug Facts Label” directions on OTC products for proper use. They can encourage them to read the labels of OTC products thoroughly and always ask questions if they are uncertain about their choice and proper use. Patient advocacy: Pharmacists advocate for their patients’ health and well-being.

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Health and Personal Care Stores Grocery Stores Labelling Dosage 97

Community Pharmacy

FEBRUARY 15, 2023

Additional indicators that you’ve found a quality fish oil source are third-party certification of efficacy, and clearly labeled harvesting sources in terms of water quality and fish type. For typical adult males, the total recommended dosage of fish oil is around 1,500 mg per day. For women, this level drops to around 1,000 mg.

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Community Pharmacies Dosage Labelling 52

GMPSOP

AUGUST 11, 2024

Documentation : Keeping detailed records of orders, specifications, manufacturing processes, packaging, and labeling to ensure traceability and compliance. Packaging and labeling operations for investigational products are often complex and must meet specific requirements to ensure the integrity of clinical trials. Subscribe 6.

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Packaging Documentation Labelling Dosage 52

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. Incidences of these fraudulent products have posed grave threats to individuals relying on medications for their well-being.

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Adverse Reactions Packaging Documentation Dosage 103

RX Note

DECEMBER 16, 2023

I did not identify any errors on medication label and the quantity prepared. Medication Dosages Outpatient pharmacies are often high-pressure environments, with pharmacists feeling the need to rush medication preparation, but vigilance is key. The prescription was a simple one: T. Sertraline 100 mg OD. Gliclazide MR 120 mg BD.

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Labelling Dosage Medication Labelling Packaging 52

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.

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Hospitals Dosage Labelling 52