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News|Articles|September 27, 2023

FDA Approves Metronidazole Oral Suspension

This antibiotic is the only liquid oral suspension approved in the US.

This week, Appili Therapeutics announced its announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, received FDA approval for metronidazole Oral Suspension 500mg/5mL (ATI-1501). ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole, has been licensed to Saptalis for commercialization in the US, and other selected territories. The FDA also approved Likmez as the brand name for ATI-1501.

Metronidazole is an oral treatment indicated for parasitic and anaerobic bacterial infections. The current tablet form of metronidazole is the only other approved oral form on the US market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges.

“We are pleased with the approval of the NDA for Likmez,” Polireddy Dondeti, PhD, president and CEO at Saptalis, said in a statement. “We are proud of our team which, using Appili’s taste masking technology, has successfully developed a commercial product approved by the FDA. LIKMEZ will address a clear market need in a more convenient dosage form of metronidazole, and we are prepared to initiate marketing and distribution activities in the very near future.”

Appili says over 10 million prescriptions are written annually in the United States.

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