<!– –> <!– Page Last Updated: 03/03/2017 –> Page Last Updated: 03/03/2017 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…
Orange Book Data Files
<!– –> <!– Page Last Updated: 02/24/2017 –> Page Last Updated: 02/24/2017 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…
La FDA advierte acerca de reacciones alérgicas poco comunes pero graves del antiséptico tópico con gluconato de clorhexidina
La Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) advierte que se han reportado reacciones alérgicas poco comunes pero graves con los ampliamente utilizados productos antisépticos tópicos que contienen gluconato de clorhexidina. Si bien son poco comunes, el número de reportes de reacciones alérgicas graves por estos productos ha…
Dear Health Care Provider Letters: Improving Communication of Important Safety Information
%PDF-1.5% 880 0 objendobj 886 0 obj/Filter/FlateDecode/ID[]/Index[880 13]/Info 879 0 R/Length 51/Prev 124696/Root 881 0 R/Size 893/Type/XRef/W[1 2 1]stream hbbd“b`f
FDA Drug Safety Communication: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate
The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the…
Dermatologic and Ophthalmic Drugs Advisory Committee Roster
<!– –> <!– Page Last Updated: 01/25/2017 –> Page Last Updated: 01/25/2017 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…
Assessment of Abuse Potential of Drugs
%PDF-1.5% 1257 0 objendobj 1267 0 obj/Filter/FlateDecode/ID[]/Index[1257 23]/Info 1256 0 R/Length 61/Prev 272344/Root 1258 0 R/Size 1280/Type/XRef/W[1 2 1]stream hbbd“b`$gn z
La FDA revisa la descripción de los efectos secundarios para la salud mental de los medicamentos para dejar de fumar Chantix (vareniclina) y Zyban (bupropión) para reflejar las conclusiones de estudio clínico
[12-16-2016] Según una revisión de la Administración de Alimentos y Medicamentos de Estados Unidos (FDA) de un estudio clínico amplio que exigimos realizar a las compañías farmacéuticas1, hemos determinado que el riesgo de efectos secundarios graves sobre el estado de ánimo, comportamiento o pensamiento con los medicamentos para dejar de fumar Chantix (vareniclina) y Zyban…
ANDA Submissions — Refuse-to-Receive Standards Rev.2
%PDF-1.5% 1345 0 objendobj 1351 0 obj/Filter/FlateDecode/ID[]/Index[1345 13]/Info 1344 0 R/Length 52/Prev 197590/Root 1346 0 R/Size 1358/Type/XRef/W[1 2 1]stream hbbd“b`63 $V301^
FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings
[12-16-2016] Based on a U.S. Food and Drug Administration (FDA) review of a large clinical trial that we required the drug companies to conduct,1 we have determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion)* is lower than previously suspected. The risk of…