Radius Health, Inc., a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for Abaloparatide-SC.
In a notice received from the FDA late last week, the Prescription Drug User Fee Act (PDUFA) date for Abaloparatide-SC has been extended to June 30, 2017.
The FDA extended the action date to allow time to review information submitted by Radius Health in response to the FDA’s information requests. The FDA stated that the PDUFA goal date has been extended by three months to allow for a full review of the submission. In the letter, the FDA has not requested any additional information from the company.
“Our primary goal is to bring treatment to patients with postmenopausal osteoporosis as quickly as possible. We appreciate the efforts of the FDA to conduct a complete review of all of the data supporting our NDA and we remain committed to working closely with them throughout the remainder of the regulatory process,” said Robert Ward, President and Chief Executive Officer of Radius Health.
(Source: Globe Newswire)
Filed Under: Drug Discovery