BLAINVILLE, QC (CANADA), March 17th, 2015 - Duchesnay Inc. announces that following a standard review period, its partner Tzamal Medical Group – through its pharmaceutical arm, Tzamal Bio Pharma Ltd - has been granted market authorization by the Israeli Ministry of Health to promote and distribute Diclectin® in Israel. Diclectin® for nausea and vomiting of pregnancy (NVP) has a long and outstanding track record of safety and efficacy being available to Canadian women for over 30 years.
Diclectin® is the only indicated and approved medicine in Israel for the management of nausea and vomiting of pregnancy (NVP), commonly known as morning sickness. Diclectin® now offers a safe and effective option to over 170,000 Israeli pregnant women. Following the US approval by FDA in April 2013 under the trade name Diclegis®, Duchesnay has taken a further step forward with this expansion overseas.
"Approval by this third national health agency proves again the safety and efficacy of Diclectin as medication of choice to treat morning sickness, a medical condition affecting up to 85 percent of all pregnant women" said Éric Gervais, Executive Vice-President of Duchesnay Inc . "Furthermore Diclectin is produced at our Blainville plant for all markets" said E. Gervais.
"Diclectin has such an impeccable efficacy and safety record proven in North America. It is recommended as first line treatment by both the Society Obstetricians and Gynaecologists of Canada (SOGC) and the American College of Obstetricians and Gynaecologists (ACOG)" said Edi Steinberg, CEO of Tzamal Medical Group.
Diclectin®, a delayed-release combination of doxylamine and vitamin B6, is the only antinauseant and antiemetic drug labelled and approved for use in pregnancy in USA and Canada. Its long and outstanding record of accomplishment of safety and efficacy has made Diclectin® the medicine of choice in Canada for over 30 years – the recent FDA's approval of Diclegis® may allow the same in the United States. The FDA has assigned Diclegis® the highest safety rating possible which is Category A.
Duchesnay Inc. is a Canadian specialty pharmaceutical company dedicated to improve the health and quality of life of pregnant women by working at advancing maternal-fetal medicine to reduce the risk of birth defects and by developing safe and effective pharmacological solutions for use during pregnancy and breastfeeding. For more information, visit http://www.duchesnay.com/en/.
ABOUT TZAMAL MEDICAL GROUP
Tzamal Medical Group is a leading provider of pharmaceuticals, medical devices and equipment for the global healthcare industry. Tzamal Medical Group promotes leading global healthcare and creates leverage both in the Israeli and global medical markets. For more information on the group and its pharmaceutical arm - Tzamal Bio Pharma Ltd - visit www.tzamal-medical.co.il