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Glaxo cleared to restart US sales | London Evening Standard

DRUGS giant GlaxoSmithKline expects to restart sales of two key treatments in the US this summer after taking a huge step toward resolving yet another damaging spat with American regulators. The company has struck an agreement with the US Food and Drug Administration that will see it escape without a fine after an investigation found a series of problems at its Puerto Rico plant.

Glaxo cleared to restart US sales

DRUGS giant GlaxoSmithKline expects to restart sales of two key treatments in the US this summer after taking a huge step toward resolving yet another damaging spat with American regulators. The company has struck an agreement with the US Food and Drug Administration that will see it escape without a fine after an investigation found a series of problems at its Puerto Rico plant.

It was forced to halt production of anti-depressant Paxil and diabetes drug Avandamet at the site after officials found some drugs were breaking up and others contained the wrong dosages.

Despite having to post a $650m (£341m) letter of credit to US authorities for 90 days until the problem product is 'destroyed or reconditioned', Glaxo insiders were breathing a huge sigh of relief.

The news is also a boost for SkyePharma, the British biotech that gets a royalty on Paxil sales. A Glaxo spokesman said: 'This is a very positive step forward for GSK in resolving these issues.'

The company was today due to post first-quarter profits of £1.5bn.