FDA Law Blog: Biosimilars

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

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FDA Law Blog: Biosimilars

JULY 31, 2023

Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. Letter from Congress of the United States, to Robert Patterson, Acting Administrator, DEA (Dec. Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. 78,282 (Dec. codified at 21 C.F.R. b)(5)(ii)).

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

. § 314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” But in 2020, a Citizen Petition came along looking to upend FDA’s approach to strength.

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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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RX Note

AUGUST 23, 2023

The album includes photos of the drugs, as well as descriptions of their colour, shape, dosage form, taste (where applicable) and in-use shelf life. My Project I have initiated a drug album project in April 2022 that covers the most common drugs that are dispensed at my outpatient pharmacy.

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PharmaShots

FEBRUARY 28, 2023

Elyxyb is expected to be available in the US in Q2’23 through its wholly owned subsidiary, Scilex & has been approved in the US on May 2020 for the treatment of acute migraine with or without aura in adults, based on the 2 P-III trials. mL) & the maximum dosage in a 24hr. period is 120mg.

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pharmaphorum

NOVEMBER 2, 2022

A benefit of this approach, according to Nadarajah, is that though the therapeutic can be used alongside traditional painkillers, the company’s real world studies show that patients using the digital therapeutic are able to reduce painkiller dosage and potentially stop them completely. Making breakthroughs.

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pharmaphorum

SEPTEMBER 28, 2022

“For example, in early 2020, we enrolled somewhere between 3,000 to 3,500 participants each week. In March 2020, when the pandemic hit, we had to pause in-person recruitment. Understanding these differences across diverse populations can help doctors and HCPs determine what medication and dosage best fit a patient.

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RX Note

JANUARY 21, 2023

Adverse Drug Reaction Drug Induced Diseases, 2018 Meyler's Side Effects of Drugs, 2015 Antibiotics The Sanford Guide to Antimicrobial Therapy, 2022 Breastfeeding Briggs' Drugs in Pregnancy and Lactation, 2021 Hale's Medications and Mothers' Milk, 2021 Clinical Practice Applied Therapeutics, 2018 Conn’s Current Therapy, 2022 Current Medical Diagnosis (..)

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RX Note

MARCH 10, 2023

Uses and off-label use (with recommended dosage) Oral medication administration Advice to patients and Essential points, such as adverse drug reaction and role in therapy. A section of handy notes with proper citation is created at the end of each drug. The information is organised in following sequence (where appropriate).

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Viseven

JULY 26, 2022

Digital health app providers added over 90,000 new apps to app stores in 2020. Such healthcare mobile apps for patients can calculate dosage or offer dosing suggestions based on multiple complex formulas and individual medical parameters. The app can calculate dosage and the frequency of administering a pill or suspension.

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European Pharmaceutical Review

AUGUST 22, 2022

pH of a slurry of the solid oral dosage form? 25 June 2020. EMA/369136/2020. Presented to: Prescription/Non-Prescription Stakeholder Forum November 19, 2020. The risk assessment can now be simplified into three major factors: Are nitrites likely to be present in excipients? What is the pH (for liquid and semi?solid

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The Thyroid Pharmacist

OCTOBER 21, 2022

I typically recommend the following dosages. These are my recommended dosages, but please consult with your functional medicine practitioner to determine the dosage that is appropriate for you. 18) I recommend starting out slowly and building up to a therapeutic dosage of as much as 4000 mg of a supplement such as Rootcology S.

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Big Molecule Watch

SEPTEMBER 24, 2024

Lilly’s suit marks the third lawsuit against the FDA since 2020 challenging the agency’s decision to classify a product as a drug rather than a biological product. 2020), the district court upheld the FDA’s conclusion that Teva’s Copaxone was a drug rather than a biological product because it did not possess a specific, defined sequence.

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RX Note

NOVEMBER 12, 2024

In my experience, there are increasingly more off-label uses and dosages included in this resource. Contents Apart from providing comprehensive drug information, I generally find the Clinical Teaching section in Drug Reference to be potentially useful in medication counselling , although it is not written in layman's language.

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RX Note

MAY 27, 2023

The question seemed simple enough: whether dosage adjustments were needed for metronidazole in obese patient. Introduction I can still recall a memorable incident during my provisional registered pharmacist year when I received a phone call from a doctor during an on-call shift.

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FDA Law Blog: Biosimilars

MARCH 26, 2024

Because a “drug product” is defined by regulation as a “Finished dosage form. that contains a drug substance ,” FTC explains that “only those [patents] that claim the finished dosage form containing the drug substance of the relevant NDA” can be listed. Teva’s patents do not meet that criterion.

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European Pharmaceutical Review

JUNE 24, 2022

These events led to the publication of the EU Pharmaceuticals Strategy in 2020, 1 which, in addition to a range of other activities, aims to ensure the regulatory system for human medicines is future?proof Brussels; 2020. London: Office of Health Economics; 2020. proof and crisis-resistant. Future outlook.

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RX Note

AUGUST 4, 2023

In terms of knowledge, I generally divide the preparations into 2 key parts: Familiar yourself with common oral medications that you probably encounter in a daily basic (including both indications and dosage).

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

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The Thyroid Pharmacist

AUGUST 18, 2023

Research has shown plasma concentrations of curcumin as low as 50 ng/mL after administration of dosages as high as 12 g/day. The dosage I used when working to detox my body of arsenic was 500 mg, three times per day. Headaches and nausea have been noted in a small number of people at dosages over 450 mg. Published 2020 Nov 18.

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RX Note

JANUARY 11, 2024

The dosage of all products marketed for dry eye is largely dependent on the patient's need for lubrication, and is therefore given on an as-needed basis. External Links TFOS DEWS II Definition and Classification Report, 2017 Master the Maze of Artificial Tears, 2018 Artificial Tears: What Matters and Why, 2020

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RX Note

SEPTEMBER 10, 2023

NOTE: While creatinine is commonly utilized, it is not perfect as creatinine is a metabolic by-product of muscle catabolism, meaning patients with lower or higher than average muscle will demonstrate different values than expected based on their renal function.

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Pharma in Brief

JUNE 21, 2020

On June 19, 2020, the Patented Medicine Prices Review Board ( PMPRB ) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. They will be available for public comment until July 20, 2020. They will be available for public comment until July 20, 2020. Background.

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PharmaState Academy

OCTOBER 20, 2023

a) It has no impact b) It improves medication taste c) It simplifies dosage instructions d) It provides discounts on medications 9 / 20 According to a study in the Journal of General Internal Medicine, what percentage of patients feel rushed during doctor's appointments?

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Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”.

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Express Pharma

MARCH 20, 2025

Expanded capabilities across the value chain: India has also enhanced its position in the operations value chain by demonstrating broader capabilities across more complex dosages and large molecules.

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European Pharmaceutical Review

MARCH 1, 2023

X-ray technology is also increasingly used in pharmaceutical R&D, particularly for examining solid dosage forms, an application for which this technology can be seamlessly adopted. About the authors Teresa Siegert studied chemistry at the University of Regensburg and received her Master’s degree in 2020. Hancock BC, Mullarney MP.

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RX Note

FEBRUARY 3, 2024

The Importance Dispensing is defined as the provision of medicine which involves Verifying prescription validity Checking dosages and potential drug interactions Counselling patients on proper medication use This process helps reduce medication errors and optimize patient safety.

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PharmaState Academy

MAY 16, 2023

PFS are ready to use disposable syringes containing premeasured dosage of the medicine. Biologics vs. small molecules: Drug costs and patient access – ScienceDirect [[Accessed 14 October 2020] 7. J. New York Times How to decrease prices for an expensive class of drugs [link] (2015) [Accessed 14 April 2020] 10.

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Pharmacy Joe

JANUARY 10, 2021

Most recently, in December 2020 in Academic Emergency Medicine researchers published a non-inferiority randomized trial comparing the analgesic efficacy of 3 doses of intravenous ketorolac (10, 20, and 30mg) in adult patients presenting to the ED with renal colic. 165 patients were split evenly between the 3 groups.

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RX Note

JUNE 30, 2023

He was seeking guidance on the appropriate oral dosage for a CKD patient with creatinine clearance (CrCl) of 0.41ml/min. CrCl 30 to 80 ml/minute: No dosage adjustment necessary. Dosage A prescription of metformin at a dosage of 3 g once daily. He wanted to switch a patient from IV Augmentin to the oral form.

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RX Note

SEPTEMBER 8, 2023

NOTE: While creatinine is commonly utilized, it is not perfect as creatinine is a metabolic by-product of muscle catabolism, meaning patients with lower or higher than average muscle will demonstrate different values than expected based on their renal function.

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RX Note

JULY 29, 2023

Hence, maintenance dosage (on a mg/kg/day basis) are generally smaller than those of adults. Folic acid (oral) British National Formulary for Children 2020-2021 : Folate-deficiency megaloblastic anaemia Neonate, initially 500 micrograms/kg once daily for up to 4 months Child 1-11 months, initially 500 micrograms/kg once daily (max.

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FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

OPDP also specifically notes that the DOSAGE AND ADMINISTRATION section of the labeling for UBRELVY says, “If needed, a second dose may be taken at least 2 hours after the initial dose,” (emphasis added), adding to the misleading nature of the TV ad. on March 10, 2020.

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RX Note

JUNE 18, 2023

Dosage adjustment is required in renal impairment for alogliptin, sitagliptin, saxagliptin and vildagliptin. External Links Rang & Dale’s Pharmacology, 2019 Clinical Pharmacy and Therapeutics, 2018 Management of Type 2 Diabetes Mellitus, 2020 This in turn decreases blood glucose and increases insulin secretion.

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Pharmacy Friday Pearls

OCTOBER 3, 2022

2020 Case report (n=1) Rocuronium for paralysis during CABG for MG patient induced with fentanyl and midazolam Patient intubated following ~0.3mg/kg of rocuronium and successfully extubated the following morning (without sugammadex) Jung et al., Rocuronium Succinylcholine Dose 0.3 – 0.6 mg/kg 1.5 – 2.0 Overview of Evidence. mg/kg Chan et al.,1993

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