Breckenridge Pharmaceutical Gains FDA Approval for New Drug
Breckenridge Pharmaceutical Celebrates New FDA Approval
Breckenridge Pharmaceutical, Inc., a notable player in the pharmaceutical sector, has achieved a significant milestone with the recent approval from the Food and Drug Administration (FDA). The approval pertains to their Dehydrated Alcohol Injection, USP, which is now available in Single-Dose Vials containing 5 mL of ? 99% by volume ethyl alcohol. This approval marks Breckenridge as one of the pioneers in introducing a generic version of the previously exclusive drug Ablysinol®.
What is Dehydrated Alcohol Injection?
Dehydrated Alcohol Injection is formulated as a sterile and preservative-free solution containing high-purity ethyl alcohol. Designed to meet stringent quality and purity benchmarks established by the United States Pharmacopeia (USP), this injection is primarily intended for patients experiencing symptomatic hypertrophic obstructive cardiomyopathy (HOCM). It serves to induce controlled cardiac septal infarction, thereby helping improve the exercise capacity of adult patients who aren't suitable candidates for surgical procedures.
Impact on Patient Care
This approval not only showcases Breckenridge's commitment to healthcare innovation but also aligns with their strategy to enhance presence in the institutional healthcare channel. Breckenridge aims to broaden its portfolio, focusing on various therapeutic areas including oncology, autoimmune conditions, and supportive care. This expansion emphasizes their mission to deliver affordable medications, enhancing accessibility for patients across the United States.
Commitment to Quality and Service
Breckenridge Pharmaceutical stands out in the industry due to its dedication to quality service and reliable supply of pharmaceuticals. They engage closely with healthcare professionals and institutional partners to ensure that Dehydrated Alcohol Injection, USP, is readily available. This collaborative approach allows for effective patient treatment while supporting optimal medication use in clinical settings.
Strategic Vision of Breckenridge and Towa International
The introduction of Dehydrated Alcohol Injection is a critical step in Breckenridge's broader strategic initiative. The company remains focused on short- and mid-term goals, emphasizing not only growth but the need to adapt to evolving healthcare demands. This newly approved medication reflects Towa International's commitment to enhancing global health by making high-quality therapeutic solutions accessible to more patients.
Partnerships and Development
Breckenridge Pharmaceutical's success is backed by their collaboration with Andersen Pharma Global, a company renowned for its capabilities in drug development and supply chain management. This partnership plays an essential role in facilitating the delivery of innovative and effective healthcare products, ultimately fostering better health outcomes. With a focus on affordability, both companies strive to address the need for essential therapies among the U.S. population.
Frequently Asked Questions
What is Dehydrated Alcohol Injection used for?
Dehydrated Alcohol Injection is used to induce controlled cardiac septal infarction in patients with symptomatic hypertrophic obstructive cardiomyopathy.
Who manufactures Dehydrated Alcohol Injection?
The Dehydrated Alcohol Injection is marketed by Breckenridge Pharmaceutical, Inc., which is a subsidiary of Towa International.
Where can patients access this medication?
This medication is primarily available in hospitals, clinics, and home healthcare facilities across the country.
What are the purity standards for this injection?
The solution meets the quality and purity standards set by the United States Pharmacopeia (USP), ensuring it is suitable for medical use.
How does Breckenridge ensure patient access to treatments?
Breckenridge works closely with healthcare professionals and institutional partners to guarantee the availability and appropriate use of their medications.
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