Antibiotic Drugs; New Tests and Specifications for Doxorubicin Hydrochloride and its Dosage Forms

摘要

The Food and Drug Administration (FDA) is amending the antibiotic drug regulations by revising the accepted standards for doxorubicin hydrochloride bulk and its dosage forms to reflect advances in analytic chemistry and improvements in the manufacturing technology of this antibiotic drug. These actions are being taken at the request of a manufacturer and will provide better quality control of this product.