Roche has been cleared to market an insulin pump in the United States, which is tipped to achieve multi-million dollar sales, after a three-year paperwork wrangle.
The Swiss drug maker inherited procedural problems with the Accu-Check Spirit pump when it bought a firm called Disetronic for SFr1.6 billion ($1.27 billion) in 2003. But it took longer than expected to resolve.
The US Food and Drug Administration lifted an import ban on Monday, satisfied that it was now possible to track the production process of all the pump's parts.
"This is very significant because the pump was the main reason Roche bought Disetronic in the first place," Lombard Odier Darier Hentsch analyst Karl-Heinz Koch told swissinfo.
Sales of the device reached around $16 million (SFr20 million) in the US in 2002, just before Roche took over the world's second largest producer of insulin pumps.
But the Basel-based company would not speculate on how much revenue has been lost during the three-year sales ban in the US.
A spokesman also refused to say why it had taken three years to come to a resolution, but stressed that there was no question of the pump being faulty. Roche continued to sell the product in 30 other countries during the US ban.
"This is an important milestone for our Diabetes Care business unit and for all our employees who contributed to the achievement," said Roche diagnostics division chief executive Severin Schwan.
According to Koch, insulin pumps are a key element in the search for a new treatment known as an artificial pancreas.
Roche is among a number of pharmaceutical firms in the process of developing a new product that combines an insulin pump and a blood glucose monitoring device. Currently, patients have to use two separate machines.
"As the market moves towards continual monitoring and delivery at the same time – the holy grail of diabetes treatment – the insulin pump becomes increasingly important," said Koch.
"The pump is a critical element in the realisation of the artificial pancreas."
swissinfo, Matthew Allen and agencies
Diabetes is a chronic disease in which the pancreas does not produce any insulin or produces too little.
The World Health Organisation estimates that 300 million people will have diabetes by the year 2025.
It can lead to a number of serious conditions and complications, including hypertension, abnormal fat metabolism, blindness, kidney disease, heart attack, stroke and blood vessel damage that can block blood flow to the limbs and may necessitate amputation.
Roche is predicted to achieve SFr3 billion in sales for diabetes treatments against total sales of SFr8.7 billion in its Diagnostics Division.
Around 20% of diabetes patients in the US use insulin pumps.
The diabetes treatment market in the US is worth an estimated $0.5 billion annually.