MFDS Approves 13 New Medical Products in Q2

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 14th that a total of 13 new medical products were approved in the second quarter of this year.

The approved items include ▲5 new drugs (3 chemical, 2 bio) ▲7 orphan drugs (5 chemical, 2 bio) ▲1 newly developed medical device.

By indication, anticancer drugs were the most numerous with 6 items, including non-small cell lung cancer (Rozlytrek capsules) and prostate cancer (Nubecka tablets). Additionally, drugs for rheumatoid arthritis (Rinvoq extended-release tablets), Parkinson's disease (Equpina tablets), and macular degeneration treatment (Bioview injection) were approved.

In the medical device field, the HeartMate 3™, a mechanical circulatory support device used for patients with end-stage left ventricular heart failure, was approved.

The Ministry of Food and Drug Safety stated, "In a situation where the whole world is facing difficulties due to the spread of the novel coronavirus infection (COVID-19), we will conduct thorough and prompt reviews to ensure that medical products with secured safety and quality can be supplied as soon as possible."