FDA Approves Liquid Formulation of Levothyroxine

The Food and Drug Administration (FDA) has approved Tirosint-SOL (levothyroxine sodium oral solution; IBSA), for the treatment of hypothyroidism and thyroid stimulating hormone suppression in the management of some thyroid cancers.

Tirosint-SOL is a liquid form of levothyroxine; a synthetic form of the thyroid hormone thyroxine. The liquid form provides an alternative to patients who cannot swallow, who are fed by tube, or for children with hypothyroidism. 

Levothyroxine absorption can be affected by gastritis, celiac disease, lactose intolerance and the intake of certain foods and medications. Clinical trials of Tirosint-SOL showed that medications such as antacids and proton pump inhibitors do not appear to interfere with absorption. In addition, the requirement of waiting one hour before eating may be avoided.

“The development of a preparation, which allows these restrictions to be overcome and enables the achievement of the target (TSH) within the established limits, has long been the IBSA’s target,” said Arturo Licenziati, president of IBSA.

IBSA is aiming to have Tirosint-SOL available within 6 months. 

For more information visit IBSA-international.com.