RX Note
OCTOBER 19, 2023
Ingest Oral Medications When the ability of swallow medications is compromised, the choices are Crushing oral dosage forms Selecting a liquid formulation Selecting an alternative route of drug delivery (e.g. NOTE: Adherence to altered diet recommendations is challenging since restricting food and drink creates dissatisfaction and resistance.
FDA Law Blog: Biosimilars
MARCH 12, 2024
Each made similar points as the 3 that did delist: patents that claim the finished dosage form must be listed in the Orange Book, and the referenced patents claim the finished dosage form.
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RX Note
MARCH 25, 2023
Dosage varies, according to the heaviness and duration of bleeding: 1 to 1.5 Menorrhagia Menorrhagia is excessive (heavy) menstrual blood loss (i.e. blood loss of 60-80 ml or more period, compared with average loss of 30-40 ml), which occurs over several consecutive cycles. g 3 or 4 times daily for the first 3-5 days of each cycle.
RX Note
JUNE 12, 2023
Dosing in Hypothyroidism The dosage of levothyroxine is individualized based on clinical response and serum thyroid stimulating hormone (TSH) and/or free T4 concentrations. Individual T4 requirements correlate better with lean body weight than total body weight.
Integra X Files
DECEMBER 19, 2022
The Medicare Prescription Drug Benefit was passed into law nearly 20 years ago (2003) and implemented in 2006. The guidance goes on to delineate formulary provisions to ensure that Medicare enrollees in nursing homes are not disadvantaged by the nonavailability of dosage forms that are commonly required in the nursing home environment.
Pharmaceutical Technology
SEPTEMBER 22, 2022
AstraZeneca ’s cholesterol drug Crestor (rosuvastatin) was approved in 2003 in the US but only approved in Germany in 2008. per 1,000mg dosage compared to Amarin’s $4.14 However, despite this recent setback and increasing pressure from competing generics, Amarin remains optimistic about its international launch of Vazkepa.
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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