FDA Approves Breckenridge's Methadone Hydrochloride Injection for Pain Management and Opioid Dependence
核心洞察
Breckenridge Pharmaceutical receives FDA approval for its Methadone Hydrochloride Injection (搜索) USP, a multi-dose vial formulation.
The injection is indicated for managing severe, persistent pain (搜索) requiring extended opioid treatment when alternatives are inadequate.
It is also approved for temporary treatment of opioid dependence (搜索) in patients unable to take oral medication.
Breckenridge Pharmaceutical, Inc., a U.S. subsidiary of Towa International (搜索), has received final approval from the U.S. Food and Drug Administration (FDA) for its Methadone Hydrochloride Injection (搜索) USP, 200 mg/20 mL (10 mg/mL) Multi-Dose Vial. The company plans to launch the product immediately.
This injectable formulation of methadone hydrochloride is indicated for two primary uses: the management of severe and persistent pain (搜索) that necessitates prolonged treatment with a daily opioid analgesic (搜索), particularly when alternative treatment options are insufficient, and the temporary treatment of opioid dependence (搜索) in patients who cannot take oral medication.
Strategic Expansion
According to Breckenridge, this new product launch is in line with their short and medium-term strategy to broaden their impact on critical healthcare needs. By expanding the product range into the institutional channel, Breckenridge aims to enhance its ability to address healthcare needs across the industry with precision and efficacy. The company's focus includes introducing a range of Oncology (搜索), Autoimmune (搜索), Rare Disease and Supportive Care products to the U.S. market, aligning with Towa International (搜索)'s vision of holistic health.
"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," said Brian Guy, President and CCO of Breckenridge Pharmaceutical, Inc. "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 Methadone Hydrochloride
Methadone hydrochloride is a synthetic opioid analgesic (搜索) with multiple uses, including pain (搜索) management and the treatment of opioid use disorder (OUD). Its availability in an injectable form provides an alternative route of administration for patients who cannot take oral medications, ensuring continuity of care in various clinical settings.