The Saudi Food and Drug Authority (SFDA) has approved the registration of Skyclarys (Omaveloxolone), which was previously designated as an Orphan Drug under the SFDA Orphan Drug Program. The medication is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older, a rare inherited neurodegenerative disorder that impairs movement and significantly affects patients' quality of life.

Innovative Mechanism of Action

The Saudi Food and Drug Authority (SFDA) has approved the marketing authorization for in-vitro diagnostic medical devices that utilize biotechnology to accurately detect concentrations of antipsychotic medications in the blood. These include Quetiapine, Olanzapine, Aripiprazole, Clozapine, and Risperidone.

Regulatory Approval Based on Comprehensive Scientific Evaluation

The Saudi Food and Drug Authority (SFDA) has announced the suspension of a European pharmaceutical factory's registration. This decisive action follows an inspection, part of the SFDA's external monitoring program, which uncovered critical and fundamental violations of Good Manufacturing Practices (GMP). The suspension highlights the SFDA's commitment to safeguarding public health and ensuring the safety and quality of medicines available in Saudi Arabia.

The Saudi Food and Drug Authority (SFDA) has approved the registration of Winrevair (Sotatercept), which has been designated as an orphan drug under the SFDA Orphan Drug Program, for the treatment of pulmonary arterial hypertension (PAH) in adult patients classified as WHO Functional Class (FC) II to III, with the aim of improving exercise capacity.

Life-threatening Disease

In a move that highlights Saudi Arabia’s growing prominence in global pharmaceutical governance, the Saudi Food and Drug Authority (SFDA) has been officially elected to the Management Committee of the Medical Dictionary for Regulatory Activities (MedDRA)— becoming the sixth regulatory authority worldwid