GlaxoSmithKline has started supply of Paxil CR (paroxetine hydrochloride controlled release) tablets in pharmacies across the United States. Other markets will follow shortly thereafter. The company had voluntarily withdrawn the product in February due to manufacturing issues.
According to the company release, 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.