Gilead Sciences, Inc. (Nasdaq:GILD) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The mission of Gilead Sciences is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead Sciences has operations in North America, Europe and Asia Pacific.
Gilead Sciences yesterday 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 yesterday that Gilead Sciences' 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.
Gilead Sciences' products include Atripla, Truvada, Viread, Emtriva for the treatment of human immunodeficiency virus infection in adults; Hepsera, an oral formulation for the treatment of chronic hepatitis B; AmBisome, a amphotericin B liposome injection to treat invasive fungal infections; Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension; Ranexa for the treatment of chronic angina; Vistide, an antiviral medication for the treatment of cytomegalovirus retinitis in patients with AIDS; and Cayston, an inhaled antibiotic used as a treatment to enhance respiratory systems.
Gilead Sciences' products also comprise Tamiflu, an oral antiviral for the treatment and prevention of influenza A and B; Macugen, an intravitreal injection for the treatment of neovascular age-related macular degeneration; and Lexiscan/Rapiscan, an injection used as a pharmacologic stress agent in radionuclide myocardial perfusion imaging. Gilead Sciences' products under the Phase III clinical trials consist of Cobicistat, a pharmacoenhancer that is under evaluation as a boosting agent for HIV medicines; Elvitegravir, an oral integrase inhibitor being evaluated as part of combination therapy for HIV; Integrase Single-Tablet, a 'Quad' regimen of elvitegravir, cobicistat, tenofovir disoproxil fumarate, and emtricitabine for the treatment of HIV/AIDS in treatment-naive patients; and Aztreonam for inhalation solution for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa.