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Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

pharmaphorum

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents. The substance patent expired in 2007.

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Paediatric oral compounding: expert insights from a global study

Hospital Pharmacy Europe

Here, lead author and focus group chair Hala Fadda discusses the reasons for widespread off-label prescribing, the FIP studys rationale and main findings, compounding challenges and considerations for improving clinical practice.

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FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

pharmaphorum

The approval comes a few weeks after the biosimilar was cleared for marketing in the EU with a broader label, as it also includes diabetic macular oedema (DMO), another of Lucentis’ approved indications. Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1 billion and $1.9

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Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

pharmaphorum

Byooviz launched on 1 July at a 40% discount to Lucentis, with a label that covers use of the biosimilar for wet age-related macular degeneration (AMD), macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation. Roche has US marketing rights to the drug, and booked $1.3

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Vyvanse generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2007 for treatment and symptom control in ADHD. The manufacturer lists cocaine dependence as an off-label use. All amphetamine-derived ADHD medications belong to this schedule of drugs. Non-amphetamine-based ADHD treatments, such as Strattera , are not controlled substances.

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UK approves prescription-only melatonin drug for childhood ADHD

Pharmaceutical Technology

In July 2019, the MHRA held up Colonis for sending a letter to physicians advertising the off-label use of the drug in children and those with renal impairment. On 22 September, the MHRA expanded the label to include the use for sleep-onset insomnia in children with ADHD. Melatonin is used globally as a supplement to improve sleep.

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22 ibuprofen alternative drugs you must know

Druggist

Cuprofen is slightly more expensive than, for example, own labelled ibuprofen 400mg found in pharmacies. Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L (2007). 2007 Mar;41(3):381-90. Epub 2007 Jan 30. Cuprofen is a well-recognised brand of ibuprofen. Each Cuprofen tablet contains 400mg of ibuprofen.