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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

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Novo Nordisk blockbuster Ozempic boasts 23% sales surge in 2023

Pharmaceutical Technology

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn.

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FDA Approves First Over-the-Counter Naloxone Nasal Spray

LifeProNow

March 29, 2023: “The U.S. Other formulations and dosages of naloxone will remain available by prescription only. The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product.

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Viking’s weight loss drug enters an already crowded arena

Pharmaceutical Technology

The company hopes for results to be available in the second half of 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. Following the announcement, Brian Lian, Ph.D,

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PharmaTher and Vitruvias partner to commercialise Ketarx in US

Pharmaceutical Technology

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.

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Complex generics: Are global regulators addressing the needs?

Quality Matters

The same potential benefits can apply for so-called “complex generics” (CGx), which are generic drug products that have a complex active ingredient, formulation, dosage form, route of delivery, or are part of a drug/device combination. link] (accessed on June 12, 2023) 2 Daan J.A. link] (accessed on June 12, 2023). Shah, et al.

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Rx

RX Note

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. Rx, last updated 3 March 2023 (MDX: click here ; PDF: click here ) The updated.mdx database will be released whenever there are critical changes.