Amneal Pharmaceuticals Celebrates FDA Approval for New Injectable
Amneal Pharmaceuticals Enhances Its Injectable Portfolio
Amneal Pharmaceuticals, Inc. is excited to announce the FDA approval of an extended-release injectable suspension of risperidone. This significant advancement not only broadens Amneal’s portfolio of complex injectables but also reflects the company’s commitment to leading in advanced pharmaceutical development and manufacturing.
FDA Approval Details
The U.S. Food and Drug Administration (FDA) has granted approval for risperidone extended-release injectable suspension in multiple dosages including 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial, and 50 mg/vial. This formulation references the well-known Risperdal Consta, previously developed by Janssen. With this designation, the product is eligible for 180-day exclusivity, providing a unique market opportunity for Amneal following its planned launch in the fourth quarter of 2025.
Risperidone as a Treatment Option
This injectable suspension serves as an atypical antipsychotic medication primarily indicated for the treatment of schizophrenia. Additionally, it may be utilized alone or in combination with lithium or valproate for maintaining Bipolar I disorder. This approval marks a crucial addition to the accessible treatments for mental health conditions.
Company Leadership and Insights
Arash Dabestani, Pharm.D., Senior Vice President of Institutional at Amneal, expressed enthusiasm regarding this approval. He stated, "This achievement enhances our complex injectables portfolio with a novel long-acting treatment for mental health. The unique formulation requires advanced manufacturing techniques, emphasizing Amneal’s leadership in producing sophisticated medicinal solutions."
Adverse Reactions and Market Insights
As with any medication, risperidone extended-release injectable suspension has potential side effects. Commonly reported adverse reactions from clinical studies include headache, parkinsonism, dizziness, movement disorder, fatigue, and others. This awareness allows both healthcare professionals and patients to make informed decisions regarding the treatment.
Market Performance
According to recent data, the U.S. annual sales for risperidone extended-release injectable suspension, up to mid-year 2025, reached approximately $194 million. This significant figure indicates a robust market presence and reflects the demand for such treatment options in the mental health sector.
About Amneal Pharmaceuticals
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), is a prominent global biopharmaceutical company headquartered in Bridgewater, NJ. They are committed to enabling healthier lives through their comprehensive development, manufacturing, and distribution capabilities that encompass over 280 pharmaceuticals, mainly within the U.S. market. The company is particularly focused on expanding its Affordable Medicines segment by innovating in complex product categories and therapeutic areas that include injectables and biosimilars.
Exploring Specialty Segments
In addition to competitive medicines, Amneal also has a growing portfolio in the Specialty segment with a focus on branded pharmaceuticals aimed at treating central nervous system and endocrine disorders. The company’s AvKARE segment serves as a crucial distributor to the U.S. federal government, along with retail and institutional markets, showcasing Amneal's versatile market engagement.
Contacting Amneal
For inquiries, investors may reach out to Anthony DiMeo, VP of Investor Relations at anthony.dimeo@amneal.com. For media relations, Brandon Skop, Sr. Director of Corporate Communications, is available at Brandon.skop@amneal.com.
Frequently Asked Questions
What is risperidone extended-release injectable suspension used for?
This medication is primarily indicated for the treatment of schizophrenia and may also be used in conjunction with lithium or valproate for maintaining Bipolar I disorder.
What are the common side effects of this injectable?
Common side effects include headache, dizziness, fatigue, movement disorder, and weight gain among others.
When is the product expected to launch?
The product is anticipated to launch in the fourth quarter of 2025, following FDA approval.
What does the FDA approval mean for Amneal?
This approval strengthens Amneal's injectable portfolio, providing a competitive edge in treating mental health conditions.
Who can I contact for more information about Amneal?
Interested individuals can contact the investor relations or media relations department via the provided email addresses.
About The Author
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