Dong-A ST (Chairman Eom Dae-sig) announced on October 12 that the growth hormone product named ‘Growtropin II Injection Cartridge’ has been granted stability approval at room temperature after its initial opening. Growtropin is the first growth hormone drug developed by a Korean pharmaceutical company.

Prior to obtaining the approval, the Growtropin II injection cartridge had to be refrigerated (2~8℃) or used as soon as possible after opening. However, with this approval the cartridge can now be stored at room temperature below 25℃ for up to 10 days after opening. When refrigerated, the Growtropin II injection cartridge 30IU can be stored for up to 28 days after opening, while the Growtropin II injection cartridge 20IU can be stored for up to 21 days after opening.

The post-opening stability evaluation assesses whether the quality of a drug is maintained within the acceptable range when a finished drug product is repeatedly opened and used and whether it is stored in compliance with the approved conditions. As Dong-A ST’s Growtropin II injection cartridge is proven to remain stable for 10 days after opening when stored at room temperature (i.e. below 25℃), it has obtained approval for post-opening stability.

An official from Dong-A ST said, “With this new approval, the Growtropin II injection cartridge can now be used safely even when it is not possible to keep it refrigerated, such as during vacations or travel. We hope that the more convenient Growtropin II injection cartridge can be used safely in children suffering from pituitary growth hormone secretion disorders or childhood idiopathic short status (ISS).”

Meanwhile, Dong-A ST is conducting clinical trials on ‘Turner syndrome’, which refers to children who suffer from short stature due to a chromosomal abnormality and children with ‘SGA’ (Small for Gestational Age) whose growth has been delayed since birth, with the aim of identifying broader therapeutic benefits of Growtropin.