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FDA Approves First Prescription Fecal Transplant

The transplant is intended for hard-to-treat intestinal infections that are linked to 15,000 to 30,000 deaths a year.

Ferring
Ferring

A recent AP News article discussed the FDA’s approval of the very first pharmaceutical-grade fecal transplant to combat intestinal infections. The transplant is called Rebyota, and it’s intended for adults battling infections with Clostridium difficile (C. diff), a potentially lethal bacteria that can cause nausea, cramping and diarrhea. In the past, doctors have treated C. diff with stool samples from healthy donors. However, regulating stool banks and fecal transplant practitioners has become tedious for the FDA, which doesn’t typically regulate such procedures.

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Break out of the ordinary: see what’s new in life sciences packaging