Tirosint®, IBSA’s L-thyroxin in soft gel capsules, has been approved by the FDA for the introduction in the USA market. Effective immediately, the US Marketing Authorisation represents a milestone achievement in IBSA’s international expansion as well as a further outcome of the technological development of the company.

The approval has been released following the positive opinion of the US authorities on the filed documentation and on the GMP compliance of the manufacturing site, the new plant in Manno, Switzerland.

The USA approval of Tirosint® is particularly significant as the American authorities are strongly focussed on quality matters of thyroxin products. Already in 1997, following reports of batch-to-batch and intra-batch inconsistency of the marketed products, they had released a new guidance aiming to promote the re-assessment of the thyroxin products already on the market. In this respect, their approval of Tirosint® sounds as a clearance at the very highest level of rigorousness.

The new soft gel capsules technology used for Tirosint® allows indeed the avoidance of main problems encountered in the manufacturing of the old tablets. It results in uniform distribution of the active molecule among the capsules and in improved stability across the manufacturing process. The final outcome is a reliable thyroxin dosing.

Besides opening new frontiers to IBSA commercial expansion, this FDA approval also awards the company management’s efforts and strategies aimed to expand the proprietary technological capabilities.

Tirosint® will be marketed in a wide range of strengths as needed for a perfect tailoring of the dose on patients’ needs. The product is already approved and just launched in Switzerland whereas the EU approval procedure is on the way.

IBSA is a Swiss-based international pharmaceutical company involved in the development, manufacturing andmarketing of proprietary drugs for human use. Besides endocrinology, other company’s franchises include osteoarthritis,NSAIDs, dermatology and trans-dermal delivery technologies.

Tirosint® is a drug product containing synthetic L-3,3',5,5‘-tetraiodothyronine sodium salt [levothyroxine (T4) sodium] for oral administration as thyroid hormones substitution therapy. The product is intended for use under strict medical control and according to the specifications of the marketing authorisation, where available.