April 9, 2013
/CNW Telbec/ - Following the US approval of its morning sickness medication Diclegis by the US
Food and Drug Administration (FDA)
, the Canadian pharmaceutical company
is proud to announce that this approval sets the obstetric medicine specialty company for international expansion.
Diclegis has been available in
under the trade name Diclectin® for more than 30 years as the only prescription drug specifically indicated and approved for the management of nausea and vomiting of pregnancy (NVP), also known as morning sickness. Diclegis® will be commercialized in the US by
. The FDA granted Pregnancy Category "A" status to Diclegis, which means the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.
"The US approval of the patented drug Diclegis, (Diclectin in
) by the FDA represents an important milestone for Duchesnay as we plan for strategic expansion through international partnerships. We will leverage our long-standing and prominent expertise as an obstetric medicine company to reach key markets in
, where millions of pregnant women could beneficiate from our health products," stated Éric Gervais, Executive Vice-president of Duchesnay Inc.
Diclectin delayed-release combination of doxylamine succinate and pyridoxine hydrochloride is the only prescription antinauseant and antiemetic drug labeled and approved in
for use in pregnancy. Its long and outstanding track record of safety and efficacy has made Diclectin the drug of choice in
in the clinical guidelines of the
at the Hospital for Sick Children in
Society of Obstetricians and Gynaecologists of Canada (SOGC)
. Diclectin has been used by over two million pregnant women in
ABOUT NAUSEA AND VOMITING OF PREGNANCY (NVP)