Canada's Appili gets US FDA approval for oral antibiotic solution (updated)

Appili Therapeutics

25/09/2023 13:15

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       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)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))