Avenacy Announces Launch of Desmopressin Acetate for Injection in the U.S. Market

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Desmopressin Acetate for Injection in the United States as a therapeutic equivalent generic for DDAVP^® for Injection (Desmopressin Acetate) approved by the U.S. Food and Drug Administration. Desmopressin Acetate for Injection is multi-indicated for patients with central diabetes insipidus, hemophilia A, and von Willebrand’s disease (Type I).

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Avenacy’s Desmopressin Acetate for Injection is available in two presentations: 4 mcg per 1 mL single-dose vials, and 40 mcg per 10 mL multiple-dose vials. In line with Avenacy’s mission to champion patient safety and streamline patient care, Desmopressin Acetate for Injection will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection.

Avenacy will begin shipping Desmopressin Acetate for Injection to wholesale partners this week. The Company is supported by a global network of development and FDA-approved cGMP-certified contract manufacturing partners.

Desmopressin Acetate for Injection had U.S. sales of approximately $39 million for the twelve months ending in June 2023.¹

Approved Indications:

Central Diabetes Insipidus

Desmopressin Acetate for Injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Hemophilia A

Desmopressin Acetate for Injection is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to:

• Maintain hemostasis during surgical procedures and postoperatively
• Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

von Willebrand’s Disease (Type I)

Desmopressin Acetate for Injection is indicated for patients with mild to moderate von Willebrand's disease (Type I) with factor VIII levels greater than 5% to:

• Maintain hemostasis during surgical procedures and postoperatively
• Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Warning

Desmopressin Acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions (5.1)].

Desmopressin Acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids [see Contraindications (4) and Warnings and Precautions (5.1)].

Ensure the serum sodium concentration is normal before starting or resuming Desmopressin Acetate. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].

If hyponatremia occurs, Desmopressin Acetate may need to be temporarily or permanently discontinued [see Warnings and Precautions (5.1)].

Please see link for Full Prescribing Information including the Boxed Warning.

DDAVP^® is a registered trademark of Ferring Pharmaceuticals, Inc.

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/.

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