Novel Drug Approvals for 2021
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 21, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Adam ’s Secret Extra Strength 3000 Platinum contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Adam ’s Secret Extra Strength 3000 Platinum, a product promoted and sold for sexual enhancement on various websites, including www.adamssecret.co, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA aprueba cambios en la etiqueta para problemas intestinales (enteropat ía similar a esprue) asociada con el medicamento olmesartán medoxomil para la presión alta
El 3 de julio, 2013, La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) advirtió que el medicamento para la presión alta olmesartán medoxomil (comercializado como Benicar, Benicar HCT, Azor, Tribenzor y genéricos) ha sido asociado con problemas intestinales conocidos como enteropatía similar a esprue, y la agencia ha aprobado cambios en las etiquetas de estos medicamentos que mencionan esta inquietud. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Adam ’s Secret Extra Strength 1500 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Adam ’s Secret Extra Strength 1500, a product promoted and sold for sexual enhancement on various websites, including www.adamssecret.co and www.walmart.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte sobre reacciones poco frecuentes pero serias de hipersensibilidad a ciertos productos para el acn é de uso tópico y venta libre
[6-25-2014] La Administraci ón de Alimentos y Medicamentos de los Estados Unidos (FDA por su sigla en inglés) advirtió acerca de ciertos productos para el acné de uso tópico y venta libre que pueden causar irritación severa o reacciones alérgicas poco frecuentes pero serias y hasta potencialmente mortales. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte sobre el riesgo de menor nivel de alerta mental la ma ñana posterior al uso del medicamento Lunesta contra el insomnio (eszopiclona) y recomienda disminuir la dosis
[16 de mayo del 2014] La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por su sigla en inglés) advierte que el medicamento contra el insomnio Lunesta (eszopiclona) puede causar un menor nivel de alerta mental la mañana posterior al uso y afectar actividades que requieren atención, entre ellas, conducir. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte que el medicamento para el c áncer docetaxel puede causar síntomas de intoxicación alcohólica después del tratamiento
[6-20-2014] La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sigla en inglés) advirtió que el medicamento docetaxel para la quimioterapia intravenosa contiene etanol, también conocido como alcohol, que puede hacer que los pacientes se sientan intoxicados o ebrios durante y después del tratamiento. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte que el medicamento antipir ético y analgésico acetaminofén (paracetamol) puede causar reacciones poco comunes pero serias en la piel
El primero de agosto, 2013, La Administraci ón de Alimentos y Medicamentos (FDA por sus siglas en inglés), informó al público que se ha asociado al acetaminofén (paracetamol) con el riesgo a reacciones poco comunes pero serias en la piel. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Individual Patient Expanded Access Applications: Form FDA 3926
Procedural (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 19, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: January 15, 2021
Coronavirus (COVID-19) Update (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas
On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure
FDA and industry have to accelerate the adoption of advanced manufacturing technologies to strengthen the nation ’s public health infrastructure. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Mytilini Enterprises LLC dba Bedford Pharmacy Inc. - 486159 - 01/11/2021
Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma
Hematology/Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA-ASCO Virtual Workshop Defining a Research Agenda to Address Barriers and Solutions to Oral Anticancer Agent Adherence - 02/02/2021 - 02/03/2021
FDA-ASCO Virtual Workshop (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

DDT COA #000102: Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT)
Clinical Outcome Assessments (COA) Qualification Submissions Office of Drug Evaluation (ODE) II Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pandemic Response, Pandemic Preparation
Pandemic Recovery and Preparedness Plan (PREPP) initiative strengthens on-going COVID-19 pandemic response and our resiliency for future public health emergencies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
Due to the current public health emergency, FDA is issuing this guidance to assist sponsors in the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte de graves reacciones de la piel con el medicamento anticonvulsivo Onfi (clobazam) y ha aprobado cambios a la etiqueta
La tercera de diciembre, 2013, La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) le advirtió al público que el medicamento anticonvulsivo Onfi (clobazam) puede causar graves reacciones de la piel que son poco comunes y que pueden resultar en daño permanente y muerte. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso sobre el medicamento Mirapex (pramipexole) para la enfermedad de Parkinson y el posible riesgo de insuficiencia card íaca
19 de septiembre del 2012. La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) le informó al público sobre la posibilidad de un mayor riesgo de insuficiencia cardíaca con Mirapex (pramipexole), un medicamento usado para tratar la enfermedad de Parkinson y el síndrome de piernas inquietas. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Master File (DMF) Submissions on New FDA Form 3938 - 01/13/2021 - 01/13/2021
Drug Master File (DMF) Submissions on New FDA Form 3938 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CDER ’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid response efforts and ease the economic impact of COVID-19. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Database of Pharmacogenomic Information in Ethnic Minority Populations (dbPGxEMP)
Differences in genes can make someone more or less likely to benefit from a drug, suffer side effects, or require a dose that is different from other people. Such pharmacogenomic (PGx) information can be used to improve the medical decision-making process. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Workshop on Evaluating RWE from Observational Studies in Regulatory Decision-Making - 02/16/2021 - 02/17/2021
Workshop on Evaluating RWE from Observational Studies in Regulatory Decision-Making (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Smarter Nutrition, Inc. - 610024 - 12/28/2020
New Drug/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 12, 2021 Category: Drugs & Pharmacology Authors: Division of Human and Animal Food Operations West V Source Type: news

Infuscience, Inc. dba Bioscrip Infusion Services - 609526 - 12/21/2020
Compounding Pharmacy/Adulterated Drug Products (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 12, 2021 Category: Drugs & Pharmacology Authors: Division of Pharmaceutical Quality Operations I Source Type: news

Novel Drug Approvals for 2020
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Medical Imaging Drugs Advisory Committee Roster
This page contains the Medical Imaging Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Warning Letters 2021
Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 11, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 11, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter
Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: El uso de code ína en ciertos niños tras amigdalectomía y/o adenoidectomía puede llevar a eventos adversos poco comunes pero que pueden poner en peligro la vida o causar la muerte
El 15 de agosto del 2012: La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) está revisando los reportes sobre ciertos niños que desarrollaron efectos adversos graves o murieron, tras tomar codeína para aliviar el dolor después de una amigdalectomía y/o adenoidectomía por el síndrome de apnea obstructiva del sueño. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Casos poco comunes de quemaduras graves con el uso de analg ésicos tópicos de venta libre para el dolor muscular y articular
13 de septiembre del 2012. La Administraci ón de Alimentos y Medicamentos de Estados (FDA por sus siglas en inglés) cumple con avisar al público que se ha reportado que, en casos pocos comunes, ciertos productos de venta libre que se aplican sobre la piel para el alivio de dolor muscular y articular leve causan lesiones graves de la piel, quemaduras químicas que van de primer a tercer grado, que ocurren en el punto en que se aplican los productos. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products
Real-world data on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in our understanding. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

2020: A Strong Year for New Drug Therapy Approvals – Despite Many COVID-19 Challenges
In 2020, we approved a wide variety of new drugs never before marketed in the United States, known as"novel" drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Dr. Hahn's remarks to the Alliance for Health Policy Brazda Breakfast Briefing - 01/08/2021
Remarks by Stephen M. Hahn, MD, Commissioner of Food and Drugs, Alliance for Health Policy Brazda Breakfast Briefing, Jan. 8, 2020, Washington, DC (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Dr. Hahn's remarks to the Alliance for Health Policy Brazda Breakfast Briefing - 01/08/2021
Remarks by Stephen M. Hahn, MD, Commissioner of Food and Drugs, Alliance for Health Policy Brazda Breakfast Briefing, Jan. 8, 2020, Washington, DC (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

New Drug Therapy Approvals 2020
Summary of FDA Center for Drug Evaluation and Research ’s approvals of novel drug therapies along with approvals for biosimilars and other new approvals. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie
[10-22-2015] The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause severe liver injury mostly in patients with underlying advanced liver disease. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Drug Safety Communication: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
[06-06-2016] The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce these risks. We are requiring this information to be added to the buprenorphine and methadone drug labels along with detai...
Source: FDA Center for Drug Evaluation and Research - What's New - January 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women
FDA is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years and must not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. We are also recommending against using codeine and tramadol medicines in breastfeeding mothers due to possib...
Source: FDA Center for Drug Evaluation and Research - What's New - January 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)
[8-24-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Meeting on Patient-Focused Drug Development for Vitiligo - 03/08/2021 - 03/08/2021
On March 8th, 2021, FDA is hosting a public meeting on Patient-Focused Drug Development for Vitiligo. FDA is interested in hearing patients ’ perspectives on the impact of vitiligo on daily life and patient views on treatment approaches. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Informaci & oacute;n actualizada sobre la interacci & oacute;n entre el medicamento Victrelis (boceprevir) y ciertos medicamentos reforzados inhibidores de la proteasa del VIH
El 26 de abril del 2012, la Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público que, en estos momentos, no se recomienda tomar conjuntamente Victrelis (boceprevir), un inhibidor de la proteasa del virus de la hepatitis C (VHC) junto con ciertos inhibidores de la proteasa del virus de la inmunodeficiencia humana VIH reforzados con ritonavir, por la posibilidad de reducir la eficacia de los medicamentos, lo que puede desencadenar el aumento del VHC o VIH en la sangre (carga viral). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: January 5, 2021
Coronavirus (COVID-19) Update (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para Celexa (citalopram bromhidrato) relacionadas con el riesgo potencial de ritmo cardiaco anormal con dosis altas
El 28 de marzo del 2012, la Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) clarificó recomendaciones sobre dosis y advertencias para el antidepresivo Celexa (citalopram bromhidrato; también disponible como medicamento genérico). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: DETECTNET
Detection of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news