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In the news release, FDA Approves Duchesnay
USA's Diclegis® for Treatment of Nausea and Vomiting of Pregnancy (NVP), issued
08-Apr-2013 by Duchesnay
USA over PR Newswire, we are advised by the company that Laney Cohen's phone number should read "(212) 508-9643" rather than "(215) 508-9643" as originally issued inadvertently. The complete, corrected release follows:
FDA Approves Duchesnay USA's Diclegis® for Treatment of Nausea and Vomiting of Pregnancy (NVP)
Diclegis becomes only FDA-approved treatment for "morning sickness" in decades
April 8, 2013 /PRNewswire/ -- Duchesnay
USA today announced that the Food and Drug Administration (FDA) has granted approval for Diclegis
® (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.
i It is the only FDA-approved treatment for NVP, more commonly known as morning sickness, in more than 30 years.
The FDA granted Diclegis Pregnancy Category A status which means the results of controlled studies have not shown an increased risk to an unborn baby during pregnancy.
i,ii The two active ingredients in Diclegis that reduce nausea and vomiting in pregnancy – doxylamine succinate and pyridoxine hydrochloride, or vitamin B
6, – have been recommended as a first-line pharmacotherapy by the American Congress of Obstetricians and Gynecologists (ACOG) guidelines for the last nine years.
"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," said
Gilbert Godin, Chief Executive Officer, Duchesnay USA. "Duchesnay
USA is honored to bring the only FDA-approved treatment to help control symptoms of morning sickness to market. 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."
NVP is a medical condition that affects 70 to 85 percent of pregnant women with symptoms ranging from nausea to severe vomiting and retching that can last throughout the day.
iii,iv Some pregnant women may experience symptoms throughout their pregnancy.
"Millions of pregnant women suffering every year from nausea and vomiting of pregnancy now have a safe and effective FDA-approved treatment. Until now, women have been without an FDA-approved prescription option to help treat NVP symptoms, also known as morning sickness," said
Dr. Shannon Clark, Associate Professor, Division of Maternal and Fetal Medicine, University of Texas Medical Branch – Galveston. "Diclegis provides a safe and effective option for pregnant women. Its active ingredients are the most studied for this purpose."
Diclegis is expected to be widely available in the US by the end of
Efficacy and Safety Profile of Diclegis in Patients with Nausea and Vomiting of Pregnancy
Diclegis has proven to be a safe and effective treatment option for nausea and vomiting of Pregnancy (NVP).