Emrosi Approved to Treat Rosacea

On Nov. 4, 2024, Journey Medical announced that the US Food and Drug Administration (FDA) approved Emrosi^™ (minocycline hydrochloride extended-release) 40mg capsules to treat inflammatory lesions (papules and pustules) of rosacea in adults. Rosacea is a chronic, relapsing skin condition that causes redness and acne-like bumps on the face. Typically diagnosed for patients who are in their 30s and older, rosacea is more common among women – especially those with light complexions. It is estimated that 16 million Americans are affected by rosacea. Emrosi is a low dose minocycline formulation, an antibiotic used for skin conditions, taken orally, once daily. It demonstrated superiority over the current standard-of-care, Oracea^® (doxycycline – Galderma) 40mg capsules and placebo in reducing total inflammatory lesion count after 16 weeks of treatment with no significant safety issues. Journey Medical anticipates a launch in the late first quarter or early second quarter of 2025. For full prescribing information, click here.

Recall

PreHevbrio Withdrawn On Oct. 25, 2024, VBI Vaccines Inc. (VBI) notified the FDA that they were going to discontinue and withdraw PreHevbrio from the US market. The product is being withdrawn because VBI is no longer financially able to support the product in the market. PreHevbrio is a vaccine indicated for the prevention of infection caused by all known subtypes of the hepatitis B virus. Individuals needing to complete the three-dose vaccine series should contact their dispensing pharmacy or healthcare provider for an alternative product. For more information on the product withdrawal, see here.