GAITHERSBURG, Md. — The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.
Sigma-Tau was approved to manufacture L-asparaginase, the primary ingredient in the drug Oncaspar (pegaspargase). Sigma-Tau began seeking approval when the previous manufacturer ceased production. The drug is used to treat acute lymphoblastic leukemia, also known as ALL.