Rotigotine (Neupro patches)

 UCB manufactures Rotigotine (Neupro patches), having acquired Schwarz Pharma in 2006 after initial development by Aderis Pharmaceuticals; generics and regional variants (e.g., Otsuka in Japan) exist but UCB holds primary global rights.wikipedia+2

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Clinical trials and initial European approval (2006) for Parkinson's and RLS identified common reactions: application site reactions (redness, irritation), nausea, dizziness, somnolence, headache, fatigue, insomnia, and dyskinesia.ema.europa+1

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A 2008 US/Europe recall due to crystal formation in patches added concerns over inconsistent delivery, leading to temporary withdrawal; reintroduction in 2012 refined warnings for skin reactions and hypersensitivity.accessdata.fda+1

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Updates included impulse control disorders (gambling, hypersexuality), sudden sleep onset, hallucinations, orthostatic hypotension, peripheral edema, weight gain, and augmentation/rebound in RLS.wikipedia+1

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Current labels emphasize withdrawal syndrome (dysphoria, apathy, anxiety), fibrosis risks, atrial fibrillation, melanoma reports, and less common effects like dyspnea, pruritus, and confusional state.ucb+1

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1. https://en.wikipedia.org/wiki/Rotigotine
2. https://www.sciencedirect.com/science/article/abs/pii/S0939641114002483
3. https://www.medicines.ie/medicines/neupro-2mg-24hr-transdermal-patch-33014/doc-history
4. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021829Orig1s001s002.pdf
5. https://www.ema.europa.eu/en/documents/scientific-discussion/neupro-epar-scientific-discussion_en.pdf
6. https://firstwordpharma.com/story/1591995
7. https://www.ucb.com/solutions/products/neupro-parkinson-s-disease
8. https://www.otsuka.co.jp/en/company/newsreleases/2016/20160525_1.html