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FDA ends 7-year obesity drug drought, clearing Novo Nordisk’s Wegovy

pharmaphorum

Already approved at a lower dose as Ozempic for treating diabetes, the new 2.4 Semaglutide meanwhile is also sold by Novo Nordisk as a daily pill called Rybelsus for diabetes, but that version isn’t approved as an obesity treatment yet although a phase 3 trials programme got underway in April. Photo by i yunmai on Unsplash.

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Novo Nordisk blockbuster Ozempic boasts 23% sales surge in 2023

Pharmaceutical Technology

Originally granted approval in its largest market, the US, in 2017, Ozempic has subsequently obtained approval for three distinct dosages, 0.5mg, 1.0mg, and 2.0mg, for the treatment of type 2 diabetes. This represents a significant 83% increase in sales between 2022–2029, demonstrating a compound annual growth rate (CAGR) of 9%.

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Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept

Express Pharma

YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

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FDA ends 7-year obesity drug drought, clearing Novo Nordisk’s Wegovy

pharmaphorum

Already approved at a lower dose as Ozempic for treating diabetes, the new 2.4 Semaglutide meanwhile is also sold by Novo Nordisk as a daily pill called Rybelsus for diabetes, but that version isn’t approved as an obesity treatment yet although a phase 3 trials programme got underway in April. Photo by i yunmai on Unsplash.

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Complex generics: The need and challenges

Quality Matters

Generic drugs perform the same as versions of an already marketed brand-name drug in terms of active ingredient, dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Generics are dispensed 97% of the time when one is available. According to the U.S.

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Chronic Kidney Disease

RX Note

Treating the underlying cause , such as diabetic kidney disease, viral infections, cardiac or hepatic disorders, administration of nephrotoxic drugs. Treatment with SGLT-2 inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists may reduce the risk of kidney disease progression in patients with type 2 diabetes. g/kg/day (0.6-0.8

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Recommended Medical Reference

RX Note

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 (..)