Acella Pharmaceuticals Thanks FDA for Maintaining Access to Desiccated Thyroid Extract (DTE) Products

ALPHARETTA, Ga., March 25, 2026 /PRNewswire/ -- Acella Pharmaceuticals, manufacturer of NP Thyroid^® (Thyroid Tablets, USP), applauds the recent notice from the U.S. Food and Drug Administration (FDA) regarding desiccated thyroid extract (DTE) products.

The FDA issued a statement clarifying its August 6, 2025, notice to DTE manufacturers, importers, and distributors expressing the Agency's commitment to maintaining access to DTE for the 1.5 million patients who rely on the medication while manufacturers move through the Biologics License Application (BLA) process for the unapproved animal-derived medications.

"We appreciate the FDA's thoughtful consideration in providing this update as it supports patient access to these essential medicines while we progress toward FDA review," said Art Deas, Chief Executive Officer of Alora Pharmaceuticals, parent company of Acella Pharmaceuticals. "Our team remains focused on upholding the highest standards of quality and care for the patient community we serve. We also remain committed to providing an affordable DTE for patients who rely on them."

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 it will apply its general, risk-based enforcement approach to DTE products, including prioritizing enforcement against entities not meeting quality standards. The Agency also outlined its plans to issue draft guidance on the conditions under which it will continue to allow DTE products to remain on the market beyond August 2026 while manufacturers pursue FDA approval of their DTE products as biologics.

The full FDA update is available here.

In September 2025, Acella Pharmaceuticals, and its sister company Neuvosyn Laboratories, LLC, announced positive topline results from their Phase II randomized, double-blind controlled clinical trial evaluating North Star —an investigational DTE for the treatment of hypothyroidism for which Neuvosyn intends to pursue FDA approval as a BLA.

"Although DTE is a biological product, we do not intend to give ours a biologics price tag," said Deas. "We are proud to support the Administration and FDA in their commitment to providing affordable medicines to hardworking Americans who need them." 

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.

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 that comprise the Alora Family of Companies: Avion Pharmaceuticals, Acella Pharmaceuticals, Osmotica Pharmaceuticals, Sovereign Pharmaceuticals, Trigen Laboratories, Neuvosyn Laboratories, Vertical Pharmaceuticals, and Glendale Pharmacy.

SOURCE Alora Pharmaceuticals, LLC