Gilead Sciences Resolves FDA Warning Letter Related to San Dimas Manufacturing Facility

Gilead Sciences, Inc.

today announced that it has resolved all outstanding issues raised in a Warning Letter issued by the U.S. Food and Drug Administration (FDA) in September 2010 related to its San Dimas, California manufacturing facility. The FDA notified Gilead today that the company's response and the actions that have been adopted and implemented at the San Dimas site have sufficiently addressed the FDA's observations, which were primarily related to the manufacturing environment for AmBisome® (amphotericin B) liposome for injection, as well as general observations related to systems, procedures and controls focused on ensuring product quality at the San Dimas facility.