The Food and Drug Administration has approved Amneal Pharmaceuticals' lanreotide injection, and the company says the product launched immediately, adding another competitor to a specialty injectable that generated nearly a billion dollars in U.S. brand sales over the past year.
Amneal announced the approval on Sept. 18 for its 120 mg/0.5 mL single-dose prefilled syringe, which references Ipsen's Somatuline Depot and carries Competitive Generic Therapy designation from the FDA. In its announcement of the approval and launch, the company said the product "adds another material growth driver to our Affordable Medicines business," in the words of Srinivas Kone, senior vice president and chief scientific officer for that unit.
