Merck: FDA approves drug application
(CercleFinance.com) - The group announces that the Food and Drug Administration in the US (FDA) has approved a request for new drug (NDA) for DIFICID (fidaxomicine).
This drug is used to treat diarrhoea in children of six months and over.
The FDA has approved a New Drug Application (NDA) for DIFICID (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhoea (CDAD).
DIFICID is a macrolide antibacterial drug indicated for use in adults and paediatric patients 6 months of age and older for the treatment of DACD.
"C. difficile is an important cause of health care- and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized controlled trial of C. difficile infection treatment in children," said Dr. Larry K. Kociolek, Associate Medical Director of Infection Prevention and Control at Ann & Robert H. Lurie Children's Hospital of Chicago.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
This drug is used to treat diarrhoea in children of six months and over.
The FDA has approved a New Drug Application (NDA) for DIFICID (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhoea (CDAD).
DIFICID is a macrolide antibacterial drug indicated for use in adults and paediatric patients 6 months of age and older for the treatment of DACD.
"C. difficile is an important cause of health care- and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients. The fidaxomicin pediatric trial was the first randomized controlled trial of C. difficile infection treatment in children," said Dr. Larry K. Kociolek, Associate Medical Director of Infection Prevention and Control at Ann & Robert H. Lurie Children's Hospital of Chicago.
Copyright (c) 2020 CercleFinance.com. All rights reserved.