The U.S. Food and Drug Administration (FDA) issued a follow-up statement to its August 6, 2025, notice to desiccated thyroid extract (DTE) manufacturers. In the announcement, the FDA stated that it would “continue applying its risk-based enforcement approach to unapproved animal-derived medications …,” while reiterating that it may “take action against a manufacturer that is not meeting quality standards and putting patients at risk.”

Acella Pharmaceuticals is the maker of NP Thyroid^® (Thyroid Tablets, USP), the #1 prescribed DTE^{^} in the United States to treat adults with primary hypothyroidism. There are approximately 1.5 million American hypothyroidism patients who rely on DTE products, like NP Thyroid^®, to treat their hypothyroidism.

Hypothyroidism is a chronic condition in which the thyroid gland does not produce enough thyroid hormones to meet the body’s needs. Thyroid hormones play a critical role in regulating metabolism, energy production, heart function, and brain health. When these hormones are deficient, patients often experience fatigue, weight gain, depression, sensitivity to cold, and cognitive difficulties.

“We welcome this update as it ensures continued patient access to these vital medications while we work diligently toward formal FDA approval,” said Art Deas, Chief Executive Officer of Acella Pharmaceuticals. “Our commitment to quality and patient care has always been at the forefront of our work.”

In the announcement, the FDA also reiterated its commitment to ensuring the safety of patients currently using unapproved animal-derived thyroid medications. The FDA stated its plans to issue guidance on the conditions under which the agency will continue to allow unapproved DTE products to remain on the market beyond August 2026 while manufacturers pursue full approval of their DTE products as biologics.

The full FDA update is available here.

Acella Pharmaceuticals, LLC, has been collaborating with the FDA for the past seven years to pursue formal approval of a new DTE product using the same active pharmaceutical ingredient (API) as NP Thyroid^® through its sister company Neuvosyn Laboratories.

“We look forward to continuing toward full approval and, in the meantime, remain committed to delivering a quality treatment that meets all current good manufacturing practices and FDA requirements,” said Deas.

Patients and healthcare providers seeking additional information about NP Thyroid^®, including availability and patient resources, can visit the latest product updates and access information or explore hypothyroidism education and patient resources available on the NP Thyroid^® website.

For NP Thyroid^® full Prescribing Information, including BOXED WARNING, please visit npthyroid.com/pi

About Alora Pharmaceuticals, LLC
Alora Pharmaceuticals, LLC is the parent company of six specialty pharmaceutical and pharmaceutical manufacturing companies with manufacturing facilities in Texas and Georgia. Headquartered in Alpharetta, GA, Alora is the parent company of the following organizations the comprise the Alora Family of Companies: Avion Pharmaceuticals, Acella Pharmaceuticals, Osmotica Pharmaceuticals, Sovereign Pharmaceuticals, Trigen Laboratories, Neuvosyn Laboratories, Vertical Pharmaceuticals, and Glendale Pharmacy.