Breckenridge gets FDA OK for methadone hydrochloride injection

Breckenridge, the U.S. subsidiary of Towa International, has received the Food and Drug Administration’s clearance for methadone hydrochloride Injection, 200 mg/20 ml (10 mg/ml) multi-dose vial, which it plans to launch immediately.

Methadone hydrochloride injection, 200 mg/20 ml (10 mg/ml) multi-dose vial is indicated 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 for use in temporary treatment of opioid dependence in patients unable to take oral medication.

Breckenridge said that expanding its product range into the institutional channel broadens its impact on critical healthcare needs. 

[Read more: Breckenridge gets FDA nod for 2 generics]

“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,” the company noted.

Brian Guy, president and CCO of Breckenridge, said, "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."

Guy added, "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."

[Read more: Breckenridge obtains FDA nod for generic Jevtana]