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February 26, 2021

Public Notification: Vy & Tea contains hidden drug ingredient

[2-26-2021] The Food and Drug Administration is advising consumers not to purchase or use Vy & Tea, a product promoted and sold for weight loss on […]
February 25, 2021

Withdrawn Guidances (Drugs)

Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry 6/1/2028 2/25/2021 Content and Format for Geriatric Labeling 10/05/2001 9/15/2020 Classifying Significant Postmarketing drug […]
February 25, 2021

FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)

Podcast Welcome back to the DISCO, FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
February 25, 2021

FDA investiga infección cerebral poco común en paciente que tomó Gilenya (fingolimod)

[8/29/2013] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) alertando al público que un paciente en Europa con diagnóstico […]
February 24, 2021

Public Notification: Alpha Male Plus contains hidden drug ingredient

[2-24-2021] The Food and Drug Administration is advising consumers not to purchase or use Alpha Male Plus (also referred to as Alpha Male+), a product promoted […]
February 24, 2021

FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna)

(en Español) Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [4-20-2012] The U.S. Food and Drug Administration (FDA) is warning of possible […]
February 24, 2021

FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death

[05-19-2016] The U.S. Food and Drug Administration (FDA) is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and […]
February 24, 2021

FDA advierte acerca del riesgo de sangrado grave en antiácidos de venta libre que contienen aspirina

La Administración de Alimentos y Medicamentos de EE. UU. (FDA) advierte a los consumidores acerca del riesgo de sangrado grave al utilizar antiácidos de venta libre, […]
February 24, 2021

Untitled Letters 2018

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion’s untitled letters.  The agency may have redacted […]
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