WebFeb 1, 2024 · Animal Drugs @ FDA is an online database of FDA-approved animal drugs. It is searchable by NADA/ANADA number, Sponsor, Ingredients, Proprietary name, Dose Form, Route of Administration, Species ... Web• CDC holds an intermediate-size patient population EA-IND(IND 116,039/Protocol 6402) to allow access to and use of TPOXX for treatment of orthopoxvirus infections, including monkeypox. The EA-IND provides an umbrella regulatory coverage so that ... FDA Form 1572 [1MB, 2 pages]: One signed 1572 per facility suffices for all TPOXX
Information for Sponsor-Investigators Submitting INDs
WebOct 14, 2024 · What are INDs? An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer... WebcUse of water for oral dose preparation and administration is not in the FDA-approved labeling but is allowed under this IND protocol. IND 116,039 Tecovirimat (CDC IRB #6402) Version 6.2 Attachment 3: Opening and Mixing Tecovirimat Capsules with Food October 24, 2024 tecovirimat package insert a a b b a b a b c c pinterest sheds pole barn homes
New Streamlined Process to Provide Tecovirimat (TPOXX) for
WebThe CDC-sponsored IND 116039/Protocol #6401 is for treatment purposes only (i.e., non-research). To reduce the logistical and regulatory burden of individual hospitals or other … WebOn May 18, 2024, injection formulation of tecovirimat (brand name TPOXX) also received FDA-approval for smallpox treatment in adults and pediatric patients weighing at least 3 kg. The CDC-sponsored IND 116039/Protocol #6401 is … WebFeb 27, 2024 · Children’’ (IND 116039/CDC #6402)— New—Office of Science (OS), Centers for Disease Control and Prevention (CDC). Background and Brief Description ... Tecovirimat (TPOXX) is FDA- approved for the treatment of human smallpox disease caused by Variola virus in adults and children. However, its use for other orthopoxvirus stemless wine glass box