Begin main content

Reports

We found 4704 result(s)

ulipristal acetate (Fibristal)

Last Updated: June 21, 2017
Result type: Reports
Product Line: Common Drug Review
Generic Name: ulipristal acetate
Indications: Uterine fibroids (signs and symptoms)

  • Brand Name: Fibristal
  • Manufacturer: Allergan Inc.
  • Project Number: SF0528-000
  • Project Status: Received
  • Submission Type: RequestForAdvice

Tags

Gynecology/obstetrics

A Transdermal Glucagon Patch for Severe Hypoglycemia

Published on: June 19, 2017
Result type: Reports
opens in document viewer

Summary The ZP-Glucagon patch uses novel microneedle technology to deliver glucagon through the skin to people who are experiencing severe hypoglycemia (very low blood sugar). There is very limited evidence, from one small study, comparing the ZP-Glucagon patch with glucagon injected intramuscularly. The evidence suggests that the correction of ...

  • Project Number: EH0054-000

Flash Glucose Monitoring System for Diabetes

Published on: June 19, 2017
Result type: Reports
opens in document viewer

Summary The FreeStyle Libre Pro is a glucose monitoring system intended to replace finger-stick tests; it uses a sensor implanted in the arm that a health care provider scans with a specialized reader for a record of glucose levels, trends, and patterns in people with diabetes. The available evidence suggests that the performance and accuracy of...

  • Project Number: EH0053-000

Point-of-Care Glycated Hemoglobin Testing to Diagnose Type 2 Diabetes

Published on: June 19, 2017
Result type: Reports
opens in document viewer

Summary Glycated hemoglobin (A1C) is a marker in the blood used to monitor glycemic, or blood sugar, control in people with diabetes. Many point-of-care A1C testing devices have US regulatory approval for use in monitoring glycemic control in people with diabetes, but, as yet, none have been cleared by the FDA for the diagnosis of type 2 diabete...

  • Project Number: EH0055-000

Prevention of Plantar Ulcers in People With Diabetic Peripheral Neuropathy Using Pressure-Sensing Shoe Insoles

Published on: June 19, 2017
Result type: Reports
opens in document viewer

Summary The SurroSense Rx system is a set of pressure-sensing shoe insoles that connect wirelessly to a proprietary smartwatch and is intended for people with diabetes who have mild to moderate sensory loss associated with diabetic peripheral neuropathy, or nerve damage. By providing real-time alerts about plantar pressure distributions, or the ...

  • Project Number: EH0056-000