- Diplomat becomes distributor of recently approved cancer drug
- Senate passes Drug Quality and Security Act
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- FDA advisory panel to consider OTC status of NSAIDs
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.
“To get a complex biologic medicine, such as this, exactly right takes a great deal of work for both the manufacturer and the FDA,” Sigma-Tau CEO Gregg Lapointe said. “We are pleased to announce that with this approval, there will be no interruption in either the production of the medicine or in the treatment of patients with ALL.”