Premenstrual Dysphoric Disorder

FDA approves intermittent dosing of Paxil CR for PMDD

Published in Drug Week, March 26th, 2004

GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration approved the company's supplemental new drug application for an intermittent dosing regimen of Paxil CR (paroxetine HCl) Controlled-Release Tablets for the treatment of premenstrual dysphoric disorder (PMDD).

With the new dosing option, women suffering from PMDD can take Paxil CR once-daily during the 2-week period prior to the onset of their menstrual cycle rather than throughout the month. Paxil CR, the first and only controlled-release selective serotonin-reuptake inhibitor indicated for intermittent treatment of PMDD, is also indicated for the continuous treatment of PMDD, depression, social...

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Source: Drug Week (2004-03-26)

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