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news.GlaxoSmithKline is set to reintroduce two previously withdrawn drugs to the US market having reached an agreement with the FDA over production problems at its Puerto Rico manufacturing site.
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The drugs, Paxil CR, an antidepressant tablet and Avandamet, a diabetes medication, were seized following an FDA inspection which revealed manufacturing problems at the plant.
Glaxo believes it has identified the source of the manufacturing issues related to both products, and has already implemented revisions to those manufacturing processes. The company is now validating those solutions through a third party.
Based on the terms of the agreement, Glaxo can continue to manufacture the products at the site and expects to begin re-supplying the US and other markets with both drugs in mid-year.
News of the agreement prompted a rise in Glaxo’s share price. Investor confidence was further bolstered after the company issued a financial report showing a 17% rise in first-quarter earnings. Glaxo expects profits to continue to rise following the release of Paxil CR and Avandamet.