News

Woburn, MA — February 26, 2026 — Azurity Pharmaceuticals, Inc. announced today that Ferabright^TM (ferumoxytol injection) is now available in the U.S. Ferabright is the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.¹ Ferabright was approved by the U.S. Food and Drug Administration (FDA) in October 2025.

Woburn, MA—February 10, 2026—Azurity Pharmaceuticals, Inc. announced that ARYNTA™ (lisdexamfetamine dimesylate) Oral Solution will be available mid-2026 for treating ADHD in adults and pediatric patients 6 years and older. Arynta, a ready-to-use lisdexamfetamine oral solution that may be stored at room temperature between 68°F to 77°F (20°C to 25°C),¹ received FDA approval in June 2025.

NEW YORK, NY, UNITED STATES, January 14, 2026 — ACA Pharma and Azurity Pharmaceuticals are pleased to announce that they have entered into an exclusive distribution partnership under which ACA Pharma will commercialize Ferabright^TM (ferumoxytol injection) across Macau, Hong Kong, Singapore, the Guangdong–Hong Kong–Macao Greater Bay Area (GBA) and Mainland China.

Woburn, MA—December 18, 2025—Azurity Pharmaceuticals, Inc. announced today the availability of Javadin^TM (clonidine hydrochloride) oral solution, the only FDA-approved, immediate-release, ready-to-use oral liquid clonidine formulation for the treatment of hypertension in adult patients to lower blood pressure. Lowering blood pressure has been shown to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Woburn, MA – November 17, 2025 – Azurity Pharmaceuticals and Sebela Pharmaceuticals announced today Azurity’s successful acquisition of Sebela’s Bowel Prep Franchise, including two leading bowel preparation therapies for colonoscopies.

Woburn, MA—October 24, 2025—Azurity Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Javadin^TM (clonidine hydrochloride) oral solution, the only FDA-approved, immediate-release, ready-to-use oral liquid clonidine formulation for the treatment of hypertension in adult patients to lower blood pressure. Lowering blood pressure has been shown to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

New York, NY — October 23, 2025— ACA Pharma and Azurity Pharmaceuticals are pleased to announce that they have signed an exclusive distribution partnership agreement for ACA Pharma to commercialize Feraheme® (ferumoxytol injection) across Hong Kong, Macau, the Greater Bay Area (GBA), Mainland China, and Singapore.

Woburn, MA — October 17, 2025 — Azurity Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Ferabright™ (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.¹

FOR IMMEDIATE RELEASE Woburn, MA — July 31, 2025 — Azurity Pharmaceuticals, Inc. announced today the availability of BRYNOVIN™ (sitagliptin) oral solution, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. BRYNOVIN is not recommended in patients with type 1 diabetes and has not been studied in patients with a history of pancreatitis.

An innovative single pill combination of three medicines, including two doses that are lower than those currently available in single pill combinations, that can deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, as demonstrated in clinical trials, with an established safety profile

FOR IMMEDIATE RELEASE Woburn, MA — June 10, 2025 — Azurity Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved XIFYRM^TM (meloxicam injection) an IV non-steroidal anti-inflammatory drug (NSAID) that offers once daily dosing.

MEDIA ALERT: WOBURN, MA, March 14, 2025 – Azurity Pharmaceuticals (“Azurity”) announced today the successful completion of its acquisition of Covis Group S.à r.l. (“Covis”) from existing investors. With this acquisition, Covis is now a wholly-owned subsidiary of Azurity.

MEDIA ALERT: WOBURN, Mass. December 11, 2024 – Azurity Pharmaceuticals announced today the availability of Azmiro™, the first and only FDA-approved prefilled testosterone cypionate injection. Azmiro is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency…

MEDIA ALERT: WOBURN, Mass. Nov 14, 2024 – Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten™, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive…

MEDIA ALERT: WOBURN, Mass. September 3, 2024 – Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Nymalize^® (nimodipine) oral solution in a 30 mg/5 mL prefilled ENFit^® syringe…

MEDIA ALERT: WOBURN, Mass. May 6, 2024 – Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Myhibbin™…

MEDIA ALERT: – January 24, 2024 – Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of
Zenzedi^® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report…

MEDIA ALERT: Woburn, Mass. – September 27, 2023 – Azurity Pharmaceuticals, Inc. (“Azurity”) is pleased to announce the closing of its acquisition of Slayback Pharma LLC (“Slayback”) today from existing investors…

MEDIA ALERT: Woburn, Mass. – October 12, 2022 – Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing innovative products to serve the specific needs of overlooked…

Woburn, Mass. – September 2, 2022 – Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing innovative dose-forms and formulations of products to serve the needs of overlooked…

Woburn, Mass. – July 18, 2022 – Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing innovative products to serve the specific needs of overlooked…

Woburn, Mass. – February 18, 2022 – Azurity Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing innovative medicines that meet the specific needs of underserved…

(baclofen oral suspension)

WOBURN, MA, February 7, 2022 Azurity Pharmaceuticals, Inc., a private specialty pharmaceutical company, focused on developing innovative products to meet the unique needs of patients with underserved…

The first and only FDA-approved ready-to-use liquid topiramate

WOBURN, MA, November 8, 2021-Azurity Pharmaceuticals, Inc. a private specialty pharmaceutical company focused on developing innovative products to meet the unique needs of patients with underserved…

WOBURN, MA & ATLANTA, GA (September 20, 2021) – Azurity Pharmaceuticals, Inc. (“Azurity”) is pleased to announce the closing of its acquisition of Arbor Pharmaceuticals, Inc. (“Arbor”), as previously announced on August 24, 2021. The acquisition creates a leading...

FOR IMMEDIATE RELEASE – September 7, 2021 – Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle.

NovaQuest Private Equity to support the continued growth of the combined innovative, patient-centric company
WOBURN, MA & ATLANTA, GA (August 24, 2021) – Azurity Pharmaceuticals, Inc. (“Azurity”) and Arbor Pharmaceuticals, Inc. (“Arbor”) today announced they have entered into a definitive agreement in which Azurity will be acquiring Arbor from

WOBURN, Mass. (February 8, 2021) – Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today the purchase of the neurology portfolio from Eton...

WOBURN, Mass. (July 10, 2019) – Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has...