Fresenius Kabi Introduces Dalbavancin for Injection (for single-dose regimen use only)

A new addition to Fresenius Kabi’s anti-infective portfolio, Dalbavancin for Injection is indicated for acute bacterial skin and skin structure infections and approved for single-dose regimen use only

Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced Dalbavancin for Injection (for single-dose regimen use only), which is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections caused by designated susceptible strains of Gram-positive microorganisms. It is available in 500 mg vials and approved for single-dose regimen use only. The drug received FDA approval this month.

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Fresenius Kabi Dalbavancin for Injection (for single-dose regimen use only)

FDA determined Dalbavancin for Injection from Fresenius Kabi is therapeutically equivalent to the reference-listed drug DALVANCE^®1 (single-dose regimen use only).

“Dalbavancin for Injection is formulated, filled and packaged in the United States,” said Arun Verma, president of Fresenius Kabi Region U.S. and Member of the Executive Leadership Team, Fresenius Kabi AG. “This cost-effective, generic alternative for the single-dose regimen is part of our ‘More in America’ commitment to invest in American manufacturing, improve our supply chain resilience, and bring products closer to our U.S. customers.”

Since 2017, Fresenius Kabi has invested nearly $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. Learn more at moreinamerica.com.

Dalbavancin offers a 24-month shelf life.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Dalbavancin for Injection is contraindicated in patients with known hypersensitivity to dalbavancin.

WARNINGS AND PRECAUTIONS

• Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with dalbavancin for injection. If an allergic reaction occurs, discontinue treatment with dalbavancin for injection and institute appropriate therapy for the allergic reaction. Carefully monitor patients with known hypersensitivity to glycopeptides.
• Rapid intravenous infusion of dalbavancin for injection can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions.
• Alanine Aminotransferase (ALT) elevations with dalbavancin for injection treatment were reported in clinical trials.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including dalbavancin for injection. Evaluate if diarrhea occurs.

ADVERSE REACTIONS

The most common adverse reactions occurring in >4% of adult patients treated with dalbavancin for injection were nausea, headache, and diarrhea. The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS AND USAGE

Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram- positive microorganisms.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

This Important Safety Information does not include all the information needed to use Dalbavancin for Injection safely and effectively.

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to essential medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.

Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

¹ DALVANCE® is a trademark of Allergan Pharmaceuticals International Limited, an AbbVie company.

² 2023 Data on file; https://www.fda.gov/media/143406/download

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Fresenius Kabi Introduces Dalbavancin for Injection (for single-dose regimen use only)