Breckenridge announces final FDA approval for Methadone Hydrochloride Multi-Dose Injection

BERKELEY HEIGHTS, N.J., Dec. 18, 2024 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa International that markets, distributes, and sells generic pharmaceuticals in the United States, announced today that the U.S. Food and Drug Administration has granted final approval of its Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) Multi-Dose Vial which it plans to launch immediately.

Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) Multi-Dose Vial is indicated (I) for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate, and (II) for use in temporary treatment of opioid dependence in patients unable to take oral medication.

This new launch reflects the company's short and medium-term strategy, aimed at expanding its presence in the institutional channel and enhancing its portfolio. By introducing a range of Oncology, Autoimmune, Rare Disease and Supportive Care products to the U.S. market, Breckenridge demonstrates its commitment to innovation and growth. These significant strides align seamlessly with Towa International's vision of holistic health—encompassing physical, mental, and emotional well-being—echoing the World Health Organization's comprehensive definition of health.

Brian Guy, President and CCO of Breckenridge Pharmaceutical, states, "By expanding the product range into the institutional channel, we enhance our ability to broadly address critical healthcare needs across the industry with precision and efficacy. This strategic decision also underscores our dedication to meeting the evolving demands of healthcare professionals, bringing a new dimension to patient treatment for better overall care".

About Breckenridge Pharmaceutical, Inc.

Breckenridge Pharmaceutical, Inc., (New Jersey), the U.S. subsidiary of Towa International (Barcelona, Spain), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients.  With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we strive to impact the health of the patients we and our customers serve.

www.breckenridgepharma.com

For further information, please contact:

Towa International / Breckenridge Pharmaceutical, Inc.

Rosa Horri, External Comm and IR

Email: [email protected]

SOURCE Breckenridge Pharmaceutical, Inc.