Canada’s Appili gets US FDA approval for oral antibiotic solution
Sept 25 (Reuters) – The U.S. Food and Drug Administration (FDA) on Monday approved Canadian drugmaker Appili Therapeutics’ (APLI.TO) liquid oral form of antibiotic drug metronidazole, offering an alternative to patients who have difficulty taking injections or pills.
An injectable form of the drug, which is commonly used in the treatment of bacterial and parasitic infections, has been in shortage since early last year due to high demand and regulatory delays.
Appili said its partner, privately-held Saptalis, will sell the newly approved form of the drug under the brand name Likmez in the United States.
The approval of Appili’s drug could help ease the metronidazole shortage in the U.S., especially for patients in hospitalized settings and those with severe infections, who are affected most by the shortfall.
“It won’t completely solve the shortage but it could be very helpful,” said Erin Fox, senior director of drug information at the University of Utah Health.
Reporting by Bhanvi Satija in Bengaluru; Editing by Shweta Agarwal and Devika Syamnath