GlaxoSmithKline announces availability of Paxil CR to U.S. market

Jun 27 2005

GlaxoSmithKline announced today the availability of Paxil CR (paroxetine hydrochloride controlled release) tablets in pharmacies across the United States. Other markets will follow shortly thereafter.

GSK committed to resupplying pharmacies and wholesalers by mid-year after disruption of supply following the company's voluntary withdrawal of the product in February due to manufacturing issues. Both the company and the US Food and Drug Administration (FDA) agreed at the time that the manufacturing issues posed no significant safety issues for patients. GSK has identified the source of the manufacturing issues and has implemented revisions to those processes, as certified by a third party.

Paxil CR is approved for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.

With respect to Avandamet (rosiglitazone maleate/metformin hydrochloride) tablets, the Company anticipates resupplying the distribution channels within two weeks.