MerLion becomes first homegrown Singapore company to win U.S. FDA novel drug nod

SINGAPORE--MerLion Pharmaceuticals announced Wednesday that the U.S. FDA has approved an otic suspension of finafloxacin to treat acute otitis externa, commonly known as "swimmer's ear," caused by Pseudomonas aeruginosa and Staphylococcus aureus, marking it as the first novel drug from a Singapore company to achieve such status.

Finafloxacin was licensed by MerLion to a major North American partner Alcon Pharmaceuticals in 2010 for use in North America for otic (ear) infections.

FierceBiotech noted the pending approval in a Jan. 27 story, and highlighted the company's efforts to obtain more funding for further clinical trials on other potential applications and for rights outside of North America on the swimmer's ear treatment.

Among key investors is Singapore's Economic Development Board, which aided the spinoff off the company via Singapore's state-funded Agency for Science, Technology and Research, or A*STAR, at its Institute of Molecular and Cell Biology (IMCB) over a decade ago.

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