FDA News Briefs for Tuesday, July 24, 2018July 24, 2018
These Food and Drug Administration (FDA) developments came in late last week:
FDA Will Continue to Monitor Essure Adverse Events After Bayer Stops Selling Implant
Bayer has notified the FDA that the Essure permanent birth control device will no longer be sold or distributed in the United States after December 31, 2018. The FDA will continue to monitor adverse events in patients implanted with Essure after the device is withdrawn from market. In addition, the agency expects Bayer to meet all post-market obligations, including the completion of its Essure post-market study. More Information.
FDA Approves New Drug to Prevent Malaria Relapse
The FDA approved Krintafel (tafenoquine, GlaxoSmithKline) last Friday. Krintafel is a new drug indicated for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. More Information.