Avenacy Announces Launch of Zoledronic Acid Injection, USP in the U.S. Market

Represents the Company’s fifteenth product launch since inception in October 2023

SCHAUMBURG, Ill.--(BUSINESS WIRE)--Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Zoledronic Acid Injection, USP in the United States as a therapeutic generic equivalent for Zometa^® as approved by the U.S. Food and Drug Administration. Zoledronic Acid Injection, USP is indicated for the treatment of hypercalcemia of malignancy and for the treatment of multiple myeloma and bone metastases of solid tumors, in conjunction with standard antineoplastic therapy.

Avenacy's Zoledronic Acid Injection, USP is available as a 4 mg/5 mL (0.8 mg per mL) single-dose vial. In line with Avenacy’s mission to champion patient safety and streamline patient care, Zoledronic Acid Injection, USP will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection.

Avenacy will begin shipping Zoledronic Acid Injection, USP to wholesale partners this week. The Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards.

Zoledronic Acid Injection, USP had U.S. sales of approximately $11.4 million for the twelve months ending in September 2024.¹

Approved Indications:

Hypercalcemia of Malignancy

Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3.0 mmol/L] using the formula: cCa in mg/dL=Ca in mg/dL + 0.8 ( 4.0 g/dL - patient albumin [g/dL]).

Multiple Myeloma and Bone Metastases of Solid Tumors

Zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.

Limitations of Use:

The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non–tumor-related conditions have not been established.

Please see link for Full Prescribing Information.

Zometa^® is a registered trademark of Novartis.

¹Source: IQVIA

About Avenacy

Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications.

Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit http://www.avenacy.com/.