Right after a Teva ($TEVA) executive acknowledged manufacturing issues in the U.S. had whacked the legs out from under generic sales there last year, U.K. officials reported the company was having manufacturing issues there.
Teva voluntarily halted manufacturing of levothyroxine 100-mcg tablets after some patients experienced issues. The Medicines and Healthcare products Regulatory Agency (MHRA) said tests found problems with its dissolution rate.
"The manufacturer, Teva, has also been experiencing difficulties in manufacturing this product. Results of tests conducted by the MHRA's Medicines Testing Laboratory, suggest that the TEVA product may differ from other products in the amount of levothyroxine that is released over time (dissolution)," the MHRA said in a statement. “While it cannot conclusively be said that these issues prove Teva tablets are not interchangeable with other makes of levothyroxine 100 mcg tablets, the MHRA has taken prompt action as a precautionary measure,” the statement continues.
In an emailed statement, the company said, "Teva is committed to further investigation of the issues affecting supply of Levothyroxine in the UK, and is doing everything possible to resume supply as soon as possible. We are hoping to resume supply in quarter two 2012. No other markets are affected."
The agency said only the 100-mcg tablets marketed for Teva and Numark are affected. There are other makers of the drug that are ramping up supplies to help avoid a shortage. The MHRA said most patients could keep taking the medicine until they refill their prescription.
During the company's call to go over financial results, Teva CFO Eyal Desheh reported the 32% decline in revenue in the U.S. last year was primarily the result of lost sales of drugs for which the manufacture was interrupted because of manufacturing issues at plants in California and Jerusalem. He said things were looking up, however.
- see the MHRA release
- here's the MHRA statement (.pdf)
- get the earnings call transcript