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Medicines licensing

Orthostatic hypotension drug midodrine to be launched

Midodrine hydrochloride (Bramox) is due to be launched in the UK on 29 July 2015 after obtaining marketing authorisation from the medicines safety regulator MHRA.

The Medicines and Healthcare products Regulatory Agency (pictured) granted a UK licence for midodrine (Bramox) in March 2015

Midodrine hydrochloride (Bramox) is due to be launched in the UK on 29 July 2015 after obtaining marketing authorisation from the medicines safety regulator, its manufacturer has announced.

Bramox will be the first licensed product in the UK available specifically for the treatment of severe orthostatic hypotension caused by autonomic dysfunction when corrective factors have been ruled out and alternative treatments prove inadequate.

The product had previously only been available as an unlicensed special.

Brancaster Pharma, based in Reigate, Surrey, was granted a UK licence for the drug in March 2015 by the Medicines and Healthcare products Regulatory Agency (MHRA).

Brancaster’s managing director Alex Duckworth says use of unlicensed midodrine has grown substantially in the UK over the past 15 years.

The company says it has priced Bramox at 60% cheaper than the current unlicensed midodrine so the branded product has the potential to reduce the NHS drugs bill.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20069042

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  • Midodrine hydrochloride (Bramox) is due to be launched in the UK on 29 July 2015 after obtaining marketing authorisation from the medicines safety regulator MHRA.

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