Drug intelligence / Profile preview

Halodine

Development stage
Phase 4
Lead developer
Halodine
Modality
Small Molecules
Administration
Intranasal, Oral
01

Overview

Halodine is a brand name for a family of over-the-counter (OTC) topical and oral antiseptic products containing **povidone-iodine (PVP-I) at 1.25% (0.125% available iodine)**, formulated as nasal sprays, swabsticks, and oral rinses/sprays for intranasal and oral application. Marketed primarily for rapid inactivation of **SARS-CoV-2** (the virus causing COVID-19) in under 15 seconds in vitro, providing up to 4 hours of protection against viral transmission when used before/after mask-wearing, these products were developed by clinicians at Halodine LLC (initially linked to Veloce BioPharma LLC) to protect healthcare workers and the public. However, the FDA issued a warning letter in July 2021 deeming them unapproved new drugs and misbranded due to unproven claims for COVID-19 prevention/mitigation/treatment, lack of GRASE status for the indicated uses, and non-compliance with OTC antiseptic monographs (PVP-I classified Category III for most topical uses, requiring more data).[1][4][9]

Brand names
Halodine
Other names
Halodine Nasal AntisepticHalodine Nasal Antiseptic SwabstickHalodine Oral Antiseptic SprayHalodine Oral Rinse

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