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UK approves prescription-only melatonin drug for childhood ADHD

Pharmaceutical Technology

Melatonin has a prescription-only status and is strictly regulated in the UK, making this the first time it has been approved for use in this indication. 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.

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FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Pharmaceutical Technology

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). The therapy is being offered immediately through prescription for eligible ALGS patients.

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How Pharmacogenomics may finally realise its promise

pharmaphorum

More than 60 percent of all American adults take prescription drugs , amounting to approximately 131 million individuals. These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up. billion in the United States alone.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. 1435 (“Affordable Prescriptions for Patients Act of 2021”), [link] gov/bill/117th-congress/senate-bill/1435/text; H.R. Citizen Petitions before the FDA. Actavis, 570 U.S.

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Why aren’t digital pills taking off?

Pharmaceutical Technology

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Such information can then be used to inform the physician that if a particular patient’s data is not in a particular range, then that’s likely due to adherence issues, he explains.