In March 2017, the Danish pharmaceutical company, Azanta A/S obtained authorisation to market their new drug, Angusta®, tablet of 25 µg misoprostol for oral induction of labour. Angusta® is now on the market in the five Nordic countries, Denmark, Sweden, Norway, Finland and Iceland. Azanta plans to expand the availability of Angusta® by upcoming applications for authorisation in other countries.
The approval of the ready to use 25 µg tablet Angusta® is supported by a large quantity of published literature. Furthermore, the World Health Organization (WHO) and several national guidelines recommend the use of oral low dose misoprostol for induction of labour. In addition, more than 29,000 women in Denmark, Norway and Finland have had their labour induced by Angusta® under a compassionate use program initiated in 2013. The news of the approval of Angusta was well received by the Danish Society of Obstetrics and Gynaecology (DSOG).
Angusta® is approved for use with the following recommended dosing regimens:
- 25 µg orally every two hours or
- 50 µg orally every four hours according to hospital practice. The maximum dose is 200 µg over a period of 24 hours.
Azanta is pleased to be able to supply pregnant women in the Nordic countries with the first approved oral misoprostol tablet for induction of labour.