Regulators approved 13 new medical products in Q2

Shim Hyun-tai  Published 2020.07.15  17:34  Updated 2020.07.15 17:34


The Ministry of Food and Drug Safety said Wednesday that it approved 13 new medical products in the second quarter of 2020.

The three-month total breaks down into five new medicines, seven orphan drugs, and one newly developed medical device.

The Ministry of Food and Drug Safety approved 13 new medical products in the second quarter. (MFDS)

Among the newly approved drugs, anticancer treatments took the biggest part with six products, including Rozylytrek for non-small cell lung cancer and Nubeqa for prostate cancer.

Other new drugs with various indications, such as Rinvoq for rheumatoid arthritis, Equfina for Parkinson’s disease, and Beovu for macular degeneration, also obtained approval from the ministry.

In the medical device field, a newly developed ventricular assist device, HeartMate 3TM, gained approval for mechanical circulation in patients with end-stage left-sided heart failure.

“We will conduct a swift and close examination of medical products that can be provided to the public with guaranteed safety and quality as soon as possible, considering the nation and the world are having difficult times because of Covid-19,” it said.

The ministry added that it would continue to disclose user information, such as high social interest items, to the public.

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