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Regulators have found that medications containing levetiracetam and clobazam have led to drug reaction with eosinophilia and systemic symptoms (DRESS), a rare and severe drug allergy.

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Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. Aldeyra has submitted to the FDA a Special Protocol Assessment for the new trial.

source: Orexo

The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.

The results of a recent feasibility study on the outpatient administration of cell therapies is creating growing interest in whether home-based management may be possible in the future.