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SIFI S.p.A.: SIFI receives positive CHMP opinion for AKANTIOR® (polihexanide 0.08%) in acanthamoeba keratitis

ACI SANT'ANTONIO, Italy, May 31, 2024 /PRNewswire/ SIFI announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive ....

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SIFI receives positive CHMP opinion for AKANTIOR® (polihexanide 0.08%) in acanthamoeba keratitis

SIFI receives positive CHMP opinion for AKANTIOR® (polihexanide 0.08%) in acanthamoeba keratitis
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SIFI S.p.A.: SIFI RECEIVES FAVORABLE FEEDBACK FROM THE US FDA ON AKANTIOR FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS

Type B meeting feedback confirms SIFI's view that no additional data will be required for potential FDA approval of AKANTIORAKANTIOR is poised to become the first FDA-approved medication for ....

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SIFI Announces the Granting of a Second FDA Orphan Drug Designation for Polihexanide in Fungal Keratitis

/PRNewswire/ SIFI S.p.A. ("SIFI" or the "Company"), a leading international ophthalmic pharmaceutical company, announced today that the U.S. Food and Drug. ....

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SIFI SpA: SIFI Announces the Granting of a Second FDA Orphan Drug Designation for Polihexanide in Fungal Keratitis

This follows the previously granted ODD for polihexanide in Acanthamoeba Keratitis by the FDA and EMA. An estimated 15,660 patients with fungal keratitis are diagnosed annually in the ....

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