The Company has redefined foundational information for its medical food product EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI)
Entera Health, Inc. today announced that it has revised its statement of intended use for EnteraGam® to now read, “EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision.”
The company has timed the revision to coincide with the 2016 American College of Gastroenterology’s (ACG) Annual Scientific Meeting & Postgraduate Course, where Entera Health will have a booth at the Venetian in Las Vegas, NV, from Friday, October 14 to Wednesday, October 19.
To learn more about the significance of this change, visit the Entera Health booth #551 at ACG 2016 or explore the product website at enteragam.com.
About EnteraGam® / Intended Use:
EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision.
Important Safety Information:
EnteraGam® contains beef protein: therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.
EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free, and soy-free.
Please see full Product Information.
To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.For information, please contact:Aage Lauridsen, Chief Executive Officer515-963-7599