Galderma granted FDA approval for gel
Switzerland-based company Galderma Laboratories has secured Food and Drug Administration (FDA) approval for its Mirvaso topical gel product, which targets rosacea in adults.
The approval follows a 550 patient trial by the FDA which lasted for one month, as well a second trial involving 276 subjects that lasted for two months.
Lead investigator Dr Mark Jackson, a dermatologist and clinical professor of medicine at the University of Louisville, said: “The FDA approval of Mirvaso marks a turning point in rosacea treatment: we are now able to provide to patients that deal with the daily frustrations caused by the redness of rosacea with an effective therapy.”
The FDA is involved with licensing cosmetic products likely to have pharmaceutical or medicinal effects. They are also responsible for enforcing public health laws.
