Ledipasvir + Sofosbuvir is a two drug fixed-dose combination
product that include 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold internationally by Gilead Sciences Inc.
We are initiating a Phase 1b safety and pharmacokinetics trial for our candidate otoprotectant formulation, an oral, fixed-dose combination
of two antioxidant molecules HPN-07 plus n-acetylcysteine (NAC).
The approval makes it the first fixed-dose combination
HIV drug approved before its individual novel components.
He raised suspicions about the efficacy of fixed-dose combination
anti-retroviral drugs produced by generic manufacturers.
AIDS Treatment News: Recently the FDA approved two once-a-day fixed-dose combination
pills--Epzicom (Ziagen plus Epivir) from GlaxoSmithKline, and Truvada (Viread plus Emtriva) from Gilead Sciences.
US DHHS announces expedited review process by the FDA for fixed-dose combination
and co-packaged products to be used by the US in purchasing medications under PEPFAR.
Murray Lumpkin, the FDA's deputy commissioner for international and special programs, said that the FDA is "extremely hopeful" that the fixed-dose combination
pill will be particularly helpful for the HIV-infected population in the developing world.
The Drugs for Neglected Diseases Initiative in March announced that ASAQ, a fixed-dose combination
of artesunate and amodiaquine, will soon be available throughout the area where the majority of the deadly malaria cases hit.
David Nash reviews the rationale for combination therapy in treating hypertension, focusing on the fixed-dose combination
of an ARB and thiazide-type diuretic.
Emtricitabine is marketed by Gilead under the brand name Emtriva, and a fixed-dose combination
of Emtricitabine and Tenofovir Disoproxil Fumarate is made available under the brand name Truvada.
Schering-Plough Corporation (Kenilworth, NJ) announced changes to its global collaboration with Novartis for the development and commercialization of fixed-dose combination
therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
approval to market a fixed-dose combination
of the drugs.