China SFDA Orders Vital Pharma To Recall Hemorrhoid Drug
This article was originally published in PharmAsia News
China's State FDA has ordered a recall of the Zhixue (depile) hemorrhoid drug made by Vital Pharmaceutical Holdings. The agency said 21 patients developed liver problems over the past several months after taking the capsules. In addition, another 14 people have been reported with adverse effects. The SFDA also ordered Vital to stop producing the capsules as it conducts a national recall. A statement from the agency said there is an obvious connection between the damage and the capsules, but it had not determined the cause. (Click here for more
You may also be interested in...
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.