Kesin Pharma has received approval from the US Food and Drug Administration (FDA) for its new liquid formulation of metronidazole, LIKMEZ oral suspension, 500 mg/5 mL.
The first and only FDA-approved ready-to-use oral liquid metronidazole in the country, LIKMEZ is intended for patients who may struggle with dysphagia, difficulty swallowing, or high taste sensitivities.
Through partnership with Saptalis Pharmaceuticals, Kesin is the exclusive US commercialisation partner for LIKMEZ.
Kesin Pharma president and CEO Narasimhan Mani said: “An increasing number of patients can benefit from a safe and efficacious product that can support medication adherence.
“We are very excited with our first brand launch which is part of our upcoming pipeline of novel products, designed to address unmet patient needs and bring value to the healthcare system.
“We are pleased with our partnership with Saptalis Pharmaceuticals, the NDA holder and manufacturer of LIKMEZ. The timely approval of this NDA505(b)(2) presents a significant opportunity for Kesin Pharma to bring a value-added product to the market.”
The product is approved to treat trichomoniasis and anaerobic bacterial infections in adult people and amebiasis in adults as well as paediatric patients.
Available in a 200ml bottle, LIKMEZ addresses inherent risks that are associated with crushing tablets for individuals who require a liquid formulation.
Additionally, it eliminates the potential inconsistences associated with extemporaneously compounding metronidazole prescriptions.