Saptalis Pharmaceuticals, LLC has announced the commercial launch of Fluoxetine Oral Solution, USP 20 mg/5 mL, a prescription-only selective serotonin reuptake inhibitor (SSRI) formulated to address multiple mental health conditions. The oral solution is specifically designed to support flexible and individualized treatment, particularly benefiting patients who experience difficulty swallowing solid dosage forms.
Therapeutic Indications
The newly launched fluoxetine oral solution is indicated for treating several mental health conditions across both acute and maintenance phases. The medication is approved for acute and maintenance treatment of Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), and Bulimia Nervosa. Additionally, it is indicated for acute treatment of Panic Disorder, with or without agoraphobia.
Clinical Significance and Patient Access
"We are excited to expand our product portfolio with the introduction of Fluoxetine Oral Solution," said Polireddy Dondeti, Ph.D., President and CEO of Saptalis Pharmaceuticals, LLC. "This launch reflects our ongoing commitment to providing high-quality, accessible medications that meet the evolving needs of both patients and healthcare professionals."
The oral solution formulation addresses a significant clinical need for patients who cannot effectively use traditional solid dosage forms, potentially improving medication adherence and treatment outcomes in vulnerable patient populations.
Prescribing and Safety Information
Fluoxetine Oral Solution, USP 20 mg/5 mL is available by prescription only and should be used exclusively under the guidance of a licensed healthcare provider to ensure safe and effective treatment. Healthcare professionals can access full prescribing information through the company's website or by contacting Saptalis directly.
Company Background
Saptalis Pharmaceuticals, LLC is a rapidly growing specialty pharmaceutical company focused on the development, manufacturing, and commercialization of complex and high-quality generic products. The company demonstrates particular expertise in liquid and semi-solid dosage forms, operating from its headquarters in Hauppauge, New York.
The company maintains fully equipped R&D laboratories and operates a state-of-the-art commercial manufacturing facility that complies with U.S. FDA cGMP standards. Saptalis is dedicated to delivering innovative pharmaceutical solutions designed to enhance patient care and improve treatment outcomes across various therapeutic areas.
