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The FDA has granted marketing approval for injections of a drug to treat patients suffering from overproduction of growth hormones.
French pharmaceuticals firm Ipsen said the FDA has given Somatuline Depot® (lanreotide) the green light for doses of 60, 90 and 120mg to help people with acromegaly.
The approval allows the drug to be used in patients who have not responded sufficiently to surgery or radiotherapy.
Ipsen said Somatuline Depot will be available in a prefilled syringe, eliminating any need for reconstitution and enabling easy administration to patients.
In October 2006, Ipsen granted the development and commercialisation rights for Somatuline Depot to Tercica, and the firm expects to launch the drug in the USA in the fourth quarter.
Jean-Luc Belingard, chairman and CEO of Ipsen, said: “We are very proud to be able to announce that a product originated from Ipsen’s R&D will be available globally.
“This is Ipsen’s first ever FDA approval, a major achievement made possible thanks to the outstanding dedication and commitment of our teams.
“We feel confident that our partner Tercica will market Somatuline Depot very successfully by offering to patients suffering from acromegaly a new treatment option that has been proven to be effective, and very convenient to use.
“With Somatuline, Increlex, NutropinAq and its very rich pipeline of research products, Ipsen confirms its strong commitment to the progress of endocrinology worldwide.”
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