Appili Therapeutics Says FDA Approves LIKMEZ Metronidazole Oral Suspension

RTTNews | Pred 686 dňami
Appili Therapeutics Says FDA Approves LIKMEZ Metronidazole Oral Suspension

(RTTNews) - Biopharmaceutical company Appili Therapeutics, Inc. (APLI.TO, APLIF.PK) announced Monday that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC received approval from the U.S. Food and Drug Administration (FDA) 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 U.S., and other selected territories. The FDA also approved LIKMEZ as the brand name for ATI-1501.

Metronidazole is a widely used frontline oral treatment with over 10 million prescriptions written in the U.S. every year to help treat parasitic and anaerobic bacterial infections.

The current tablet form of metronidazole is the only other approved oral form on the U.S. market.

Appili expects to receive milestone payments and royalties from Saptalis based on this FDA approval and Saptalis' commercialization plans.

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