The Food and Drug Administration (FDA) has approved Duchesnay USA's Diclegis delayed-release tablet for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.
The FDA granted Diclegis Pregnancy Category A status as drug has not shown an increased risk to an unborn baby during pregnancy during controlled studies.
The active ingredients in Diclegis are doxylamine succinate and pyridoxine hydrochloride (Vitamin B6) that have been recommended as a first-line pharmacotherapy by the American Congress of Obstetricians and Gynecologists (ACOG) guidelines for the last nine years.
Duchesnay USA CEO Gilbert Godin said that the FDA approval of Diclegis provides an important new treatment to the millions of women suffering from nausea and vomiting of pregnancy, and fills a 30 year void in the treatment of NVP.
"Duchesnay has been dedicated to the health of pregnant women and their unborn children for years and is taking every step to make Diclegis available for women suffering from NVP," Godin added.
Diclegis is likely to be widely available in the US by the end of May 2013.
