MHRA Lifts Suspension on Teva Thyroid Drug
Posted 19 October 2016 | By
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced it has lifted its suspension of Israeli drugmaker Teva Pharmaceuticals' levothyroxine tablets used to treat hypothyroidism.
MHRA first suspended Teva's marketing authorization for levothyroxine tablets in 2012 following an increase in reports from patients and healthcare practitioners. However, by then, MHRA was already looking into potential differences in effectiveness for levothyroxine products as a whole.
The review found that levothyroxine tablets manufactured by Teva had significantly lower rates of dissolution than other manufacturers.
This prompted MHRA's Commission on Human Medicines (CHM) to conduct a review of the Teva's levothyroxine tablets in February 2012, which resulted in the agency suspending Teva's marketing authorization later that month.
Specifically, MHRA said it suspended the tablets over shelf-life concerns, and because the company failed to submit variations for several changes in manufacturing for the drug since 2009.
"Aware that Teva was using an unauthorized manufacturing procedure and not reassured on the basis that the product continued to meet its shelf-life specification, the MHRA advised Teva that the product should be removed from market as soon as the supply situation allowed," MHRA said.
Now, nearly four years later, MHRA says it has lifted the suspension, and is allowing Teva to market three additional strengths of the drug at 12.5, 25 and 75 micrograms.
"Teva has undertaken an extensive reformulation of the 50 and 100 microgram tablets, along with manufacturing process improvements that provide assurance of product consistency," MHRA says.
Additionally, MHRA says the availability of the new strengths of the drug will help patients control their dose by reducing the need to split tablets.