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eton pharmaceuticals announces fda approval of orphan drug alkindi® sprinkle (hYDROCORTISONE) AS REPLACEMENT THERAPY IN PEDIATRIC PATIENTS WITH ADRENOCORTICAL INSUFFICIENCY
September 29, 2020
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children. Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020.
SEE ARTICLE: https://www.globenewswire.com/news-release/2020/09/29/2101010/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Orphan-Drug-ALKINDI-SPRINKLE-hydrocortisone-as-Replacement-Therapy-in-Pediatric-Patients-with-Adrenocortical-Insufficiency.html
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children. Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020.
SEE ARTICLE: https://www.globenewswire.com/news-release/2020/09/29/2101010/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Orphan-Drug-ALKINDI-SPRINKLE-hydrocortisone-as-Replacement-Therapy-in-Pediatric-Patients-with-Adrenocortical-Insufficiency.html
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Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency
September 22, 2020
Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updates.
SEE ARTICLE: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-two-lots-np-thyroidr-thyroid-tablets?utm_medium=email&utm_source=govdelivery#recall-announcement
Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). More information can be found at www.npthyroid.com/product-updates.
SEE ARTICLE: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-two-lots-np-thyroidr-thyroid-tablets?utm_medium=email&utm_source=govdelivery#recall-announcement
adrenal insufficiency fund opens at the healthwell foundation
Copayment and Premium Assistance Now Available
September 14, 2020
GERMANTOWN, MD — The HealthWell Foundation®, an independent non-profit that provides a financial lifeline for inadequately insured Americans, has launched a new fund to provide copayment and premium assistance to patients living with adrenal insufficiency (AI).
GERMANTOWN, MD — The HealthWell Foundation®, an independent non-profit that provides a financial lifeline for inadequately insured Americans, has launched a new fund to provide copayment and premium assistance to patients living with adrenal insufficiency (AI).
PREVENTION OF ADRENAL CRISIS: CORTISOL RESPONSES TO MAJOR STRESS COMPARED TO STRESS DOSE HYDROCORTISONE DELIVERY
July 2020
A recent paper published by The Journal of Clinical Endocrinology & Metabolism* provided updated information on the most appropriate mode of hydrocortisone delivery in patients with adrenal insufficiency that are hospitalized with major surgery or major stress from severe infection. That paper can be found on our website here. https://www.nadf.us/medical-publications.html
The conclusion they came to is that continuous intravenous hydrocortisone infusion should be favored over intermittent bolus administration in the prevention and treatment of adrenal crisis during major stress. This keeps the circulating cortisol in target range over the period of time needed to treat an adrenal crisis.
*The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 7, July 2020, Pages 2262–2274, https://doi.org/10.1210/clinem/dgaa133
A recent paper published by The Journal of Clinical Endocrinology & Metabolism* provided updated information on the most appropriate mode of hydrocortisone delivery in patients with adrenal insufficiency that are hospitalized with major surgery or major stress from severe infection. That paper can be found on our website here. https://www.nadf.us/medical-publications.html
The conclusion they came to is that continuous intravenous hydrocortisone infusion should be favored over intermittent bolus administration in the prevention and treatment of adrenal crisis during major stress. This keeps the circulating cortisol in target range over the period of time needed to treat an adrenal crisis.
*The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 7, July 2020, Pages 2262–2274, https://doi.org/10.1210/clinem/dgaa133
cAH Clinical Program - Spruce biosciences
Spruce Biosciences, a late-stage clinical development company focused on developing and commercializing novel therapies for rare endocrine disorders, has announced the launch of CAHstudy.com a new website and patient resource to enable adults with Congenital Adrenal Hyperplasia (CAH) to register their interest in the CAHmelia clinical program, which is expected to commence in the second half of 2020.
exciting news from nadf
April 25, 2020
We would like to take this opportunity to make some exciting and important announcements. We have seen rapid growth of our foundation over the past decade or so, with the trajectory of growth in the responsibilities required to run NADF accelerating equally as quickly.
We would like to take this opportunity to make some exciting and important announcements. We have seen rapid growth of our foundation over the past decade or so, with the trajectory of growth in the responsibilities required to run NADF accelerating equally as quickly.
For those with adrenal insufficiency and confirmed or suspected Covid-19, increase the dose of hydrocortisone to 20 mg every 6 hours until the fever subsides, and then go back to the usual double dose until completely better.
