The decision sent Fisons' shares up 15p to 245p. The City hopes that it marks an end to the regulatory problems that have dogged the group for the past two years.
These first emerged last summer when the group disclosed that it had been forced to withdraw two of its drugs - Imferon, the blood product, and Opticrom, for eyes - because of quality control problems at its manufacturing plant.
Those problems also meant that approval for Tilade, which the group had been predicting as long as two years ago, was also delayed.
Cedric Scroggs, Fisons' chief executive, said the approval was 'an important milestone. It does show that our relations with the FDA are becoming normal again.'
It is still waiting for clearance to re-market Opticrom, but it announced that it had decided to abandon Imferon, which would have required the construction of a new manufacturing plant. That would have taken between four and six years, and the group decided the expenditure could not be justified. It is discussing licensing the product to Lotus Biochemical, the US group.
Fisons also announced that it had agreed a deal with Rhone- Poulenc Rorer, under which the Swiss group will co-promote Tilade, while Fisons will co-promote Azmacort, Rhone-Poulenc's steroid asthma treatment. The deal will give Fisons access to RPR's sales force, helping it to roll out the drug more quickly. RPR has 450 salesmen compared with Fisons' 350.
There are more than 10 million asthma sufferers in the US, and the market for treatments is estimated at pounds 622m.
The FDA also approved Manoplax, Boots' heart drug, and Paxil, the anti-depressant from SmithKline Beecham.Reuse content