FDA Decision on Ipsen’s Acromegaly Drug Upheld, Clears Path for Generics
A panel in Washington, D.C., has upheld the FDA’s decision in a case involving Ipsen’s acromegaly drug, determining that the drug does not meet the definition of a biologic under the Food, Drug, and Cosmetic Act. Ipsen had sought to have its drug classified as a biologic, which would have prevented the approval of generic…