1. Difficulty filling prescriptions for diazoxide have been reported intermittently. Teva Pharmaceuticals reports that Proglycem® Oral Suspension 50 mg/mL 30 mL (NDC 00575-6200-30) is currently available. Providers may need to direct pharmacies to place an order with their wholesale supplier.

 

  1. Tidepool has received FDA approval for its interoperable automated insulin dosing app Tidepool Loop. The app is approved for management of type 1 diabetes in people 6 years and older but is not yet commercially available. The app will ultimately be used with compatible integrated continuous glucose monitors and alternate controller enabled insulin pumps. Approval was based on the Loop Observational Study (Lum, et al; Diabetes Technol Ther 2021).

 

  1. Insulet has announced that they will be discontinuing the legacy Omnipod system (also known as Omnipod EROS) effective 12/31/23. Insulet will continue to provide support for the system beyond this date but users will need to switch to Omnipod 5 or DASH at that time.

 

  1. Trulicity® (dulaglutide) has been approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus (T2DM) — Trulicity was previously approved for this indication in adults only. Approval for the expanded indication was based on a 26-week randomized, double-blind, placebo-controlled study in 154 patients 10 years and older with T2DM that demonstrated a change in A1c of -0.8 with Trulicity vs 0.6 with placebo. The recommended pediatric starting dosage is 0.75 mg subcutaneous once weekly. Trulicity carries a boxed warning for risk of thyroid C-cell tumors.

 

  1. FDA extended approval for for IMCIVREE®(setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients 6 years and older with Bardet-Biedl syndrome (BBS) on June 16th, 2022. In addition, IMCIVREE’s label was updated to include an FDA-approved test developed under a post-marketing commitment to confirm variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) (Update Feb. 2023)
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