Issues raised were related to the manufacturing environment for AmBisome liposome and procedures in place for ensuring product quality.
Gilead Sciences is reporting that it has resolved all outstanding issues raised in a warning letter issued by FDA in September 2010 related to its San Dimas, CA, manufacturing facility. The agency has now notified the firm that Gilead’s response has sufficiently addressed the FDA’s concerns.
FDA okayed the actions adopted and implemented by Gilead at the San Dimas site. The agency’s observations had to do with 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.
AmBisome is indicated for empirical therapy for presumed fungal infection in febrile, neutropenic patients; treatment of cryptococcal meningitis in HIV-infected patients; treatment of patients with Aspergillus species, Candida species, and/or Cryptococcus species infections refractory to amphotericin B deoxycholate or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate; and treatment of visceral leishmaniasis.