Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

Hospitals 52

Hospitals Dosage Labelling 52

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. million in 2031, representing 0.6

Dosage 105

Dosage Labelling 105

The Thyroid Pharmacist

NOVEMBER 29, 2023

This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 95 expiring in March 2024.)

Health and Personal Care Stores 69

Health and Personal Care Stores Immunization Immunity Labelling 69

RX Note

AUGUST 25, 2024

A quick question: Do you know the common dosage of St. 2018 Understanding complementary medicines, 2024 Herbs at a Glance Medline Plus - Herb Memorial Sloan Kettering Cancer Center - Herb University of Rochester Medical Center - Herb John's Wort or its typical uses? In university, we often highlighted St.

Diabetes 52

Diabetes Community Pharmacies Dosage Documentation 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Rescheduling Recommendation, 2024 FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. Thirty-eight states currently authorize marijuana in different dosage formulations for specific qualifying medical conditions.

Controlled Substances 67

Controlled Substances Chemotherapy Compounding Dosage 67

FDA Law Blog: Biosimilars

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

Drug Pricing 44

Drug Pricing Biosimilars Dosage Documentation 44

FDA Law Blog: Biosimilars

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 21 U.S.C. § Basis at 63-64.

Controlled Substances 67

Controlled Substances Chemotherapy Dosage Labelling 67

Pharmaceutical Technology

JANUARY 6, 2023

At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug. In September, Novartis sent the FDA a petition, after a similar one was rejected in April 2021, asking for Entresto’s patent protection to be extended to February 2024.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS next reviewed studies investigating safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and labeling of relevant FDA-approved products. Three Republican senators on the Foreign Relations Committee advised to consider U.S.

Controlled Substances 94

Controlled Substances Chemotherapy Dosage Labelling 94