Citius Pharmaceuticals Inc. assisted the manufacturer of the active ethanol component of Mino-Lok in filing a type II drug master file with the U.S. FDA.
Mino-Lok is being developed as an adjunctive therapy to treat catheter-related or central line-associated bloodstream infection along with appropriate systemic antibiotics to salvage infected central venous catheters to preserve central venous access and avoid the complications and morbidities associated with catheter removal and reinsertion.
The manufacturer in question provides exclusivity to Citius Pharmaceuticals.
The filing is reserved for products intended for use as active pharmaceutical ingredients, and such products must meet strict FDA manufacturing and testing standards. It was determined that ethanol is an active component of Mino-Lok and not just an excipient.
In addition, the drug master file allows the company to cross-reference all manufacturing information related to the ethanol production in their regulatory applications associated with Mino-Lok therapy.
Mino-Lok is still under investigation and not approved for commercial use.