Veozah, Rexulti, Opill, Elfabrio

New FDA Approvals

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Join medical writer Dr. Emma Hitt Nichols as she relays information about the latest new FDA approvals from last week to help you stay updated. For clinicians, medical writers, medical science liasons, pharma sales reps, and other healthcare industry executives.

The FDA has approved Veozah (fezolinetant) as an oral medication for the treatment of moderate to severe hot flashes caused by menopause. Veozah is the first FDA-approved neurokinin 3 (NK3) receptor antagonist for this indication.

Rexulti (brexpiprazole) oral tablets have received supplemental FDA approval for the treatment of agitation associated with dementia due to Alzheimer's disease. This marks the first approved treatment option for this indication, addressing a challenging aspect of dementia care.

FDA advisory panels have voted in favor of making the Opill birth control pill available over the counter. While the FDA is not obligated to follow the recommendation, the decision is expected in late summer. If approved, Opill would become the first over-the-counter birth control pill in the United States.

Elfabrio (PRX-102) has been approved by the FDA for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease. Fabry disease is a rare genetic disorder characterized by the accumulation of fatty substances in various organs and tissues, leading to a range of symptoms and complications.

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