Cytotec (Misoprostol) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

Gut Microbiome: A Therapeutic Target in Chronic Liver Disease Gut Microbiome: A Therapeutic Target in Chronic Liver Disease
This review examines the role gut microbiota play in the pathogenesis and progression of chronic liver disease. Might modulation of the gut microbiome offer novel therapeutic targets?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 8, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for TX-001HR
BOCA RATON, Fla.--(BUSINESS WIRE)--Mar. 8, 2018-- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women ’s healthcare company, today announced the acceptance of the NDA for TX-001HR by the U.S. Food and Drug Administration (FDA). TX-001HR is the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

AcelRx Announces Receipt of Type A FDA Meeting Minutes and Plans to Resubmit the DSUVIA New Drug Application in Q2 2018
REDWOOD CITY, Calif., March 8, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 8, 2018 Category: Drugs & Pharmacology Source Type: news

Remifentanil (Ultiva) Lyophilized Powder for Solution Injection (Updated - Currently in Shortage)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - March 7, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA agrega advertencias acerca del riesgo de insuficiencia cardiaca a las etiquetas de los medicamentos para diabetes tipo 2 que contengan saxagliptina y alogliptina
[4-5-2016] Una revisi ón de seguridad de la Administración de Alimentos y Medicamentos de EE. UU. (FDA, por sus siglas en inglés) ha llegado a la conclusión que los medicamentos para diabetes tipo 2 que contienen saxagliptina y alogliptina pueden aumentar el riesgo de insuficiencia cardiaca, en particular en paciente s que ya tienen enfermedad cardiaca o renal. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 7, 2018 Category: Drugs & Pharmacology Source Type: news

Greer Mite Extract (Dermatophagoides Farinae and/or Dermatophagoides Pteronyssinus) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 7, 2018 Category: Drugs & Pharmacology Source Type: news

Apadaz (Benzhydrocodone and Acetaminophen) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 7, 2018 Category: Drugs & Pharmacology Source Type: news

ZTLido (Lidocaine) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 7, 2018 Category: Drugs & Pharmacology Source Type: news

House Dust Mite Injection (Dermatophagoides Pteronyssinus) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 7, 2018 Category: Drugs & Pharmacology Source Type: news

Study points to potential misuse/abuse of ADHD drugs
(Wiley) A new British Journal of Clinical Pharmacology study indicates that methylphenidate, a central nervous system stimulant approved to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, may be subject to misuse and/or abuse. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 7, 2018 Category: International Medicine & Public Health Source Type: news

Weight loss surgery linked to an increased risk of inflammatory bowel disease
(Wiley) A new Alimentary Pharmacology& Therapeutics analysis has found a link between the development of inflammatory bowel disease (IBD) and a past history of weight loss surgery. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 7, 2018 Category: International Medicine & Public Health Source Type: news

FDA Approves Trogarzo (ibalizumab-uiyk) for Treatment-Experienced Patients with Multidrug Resistant HIV
March 6, 2018 -- Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- March 6, 2018 -- Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) that expands the use of Latuda... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre casos de una infecci ón cerebral infrecuente con el medicamento para la esclerosis múltiple (EM) Gilenya (fingolimod) en dos pacientes que no habían tenido previamente exposición a medicamentos inmunodepresores
[08-04-2015] La Administraci ón de Alimentos y Medicamentos (FDA) de los Estados Unidos advierte sobre el reporte de un caso de leucoencefalopatía multifocal progresiva (LPM) definitiva y de un caso de probable LPM en pacientes que tomaban Gilenya (fingolimod) por la esclerosis múltiple (EM). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA advierte sobre casos de una infecci ó n cerebral infrecuente con el medicamento para la esclerosis m ú ltiple (EM) Gilenya (fingolimod) en dos pacientes que no hab í an tenido previamente exposici ó n a medicamentos inmunodepresores
[08-04-2015] La Administraci ó n de Alimentos y Medicamentos (FDA) de los Estados Unidos advierte sobre el reporte de un caso de leucoencefalopat í a multifocal progresiva (LPM) definitiva y de un caso de probable LPM en pacientes que tomaban Gilenya (fingolimod) por la esclerosis m ú ltiple (EM). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs
[07-04-2015] The U.S. Food and Drug Administration is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

LA FDA refuerza la advertencia que los medicamentos sin aspirina antinflamatorios no esteroides (AINES) puedan causar ataques cardiacos o derrames cerebrales
[7-9-2015] La Administraci ó n de Alimentos y Medicamentos de Estados Unidos (FDA) est á reforzando la advertencia existente de la etiqueta que los medicamentos sin aspirina antinflamatorios no esteroides (AINES) aumentan la probabilidad de ataque card í aco o derrame cerebral. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA est á evaluando los riesgos potenciales de usar medicinas para la tos y para la gripe que contengan codeína
[7-1-2015] La Administraci ón de Alimentos y Medicamentos (FDA) está investigando los posibles riesgos de utilizar medicamentos que contengan codeína para el tratamiento de tos y gripe en niños menores de 18 años de edad debido al potencial de sufrir efectos secundarios graves, incluyendo respiración lenta o dificultosa . La FDA está evaluando toda la información disponible y también consultará con expertos externos convocando un comité asesor para discutir estos problemas de salud. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

La FDA est á evaluando los riesgos potenciales de usar medicinas para la tos y para la gripe que contengan code í na
[7-1-2015] La Administraci ó n de Alimentos y Medicamentos (FDA) est á investigando los posibles riesgos de utilizar medicamentos que contengan code í na para el tratamiento de tos y gripe en ni ñ os menores de 18 a ñ os de edad debido al potencial de sufrir efectos secundarios graves, incluyendo respiraci ó n lenta o dificultosa. La FDA est á evaluando toda la informaci ó n disponible y tambi é n consultar á con expertos externos convocando un comit é asesor para discutir estos problemas de salud. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Telmisartan and Amlodipine (Twynsta) Tablets (New - Discontinuation)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Etoposide Injection (Updated - Currently in Shortage)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

New roles for pharmacists in urgent care welcomed by RPS England
NHS England has created 61 WTE new roles for pharmacists as part of its Integrated Urgent Care (IUC) programme.The initiative is supported by the Pharmacy Integration Fund. The positions are within t (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Platinol (Cisplatin for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Zenpep (Pancrelipase Delayed Release Capsules) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Colcrys (Colchicine Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Zymaxid (Gatifloxacin Ophthalmic Solution) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

Yoga vs a Low-FODMAP Diet in Patients With IBS Yoga vs a Low-FODMAP Diet in Patients With IBS
Might a yoga-based intervention or a low-FODMAP diet improve symptoms in patients with irritable bowel syndrome?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 6, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Bristol-Myers Squibb ’s Opdivo (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing
PRINCETON, N.J.--(BUSINESS WIRE) March 6, 2018 --Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo (nivolumab)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 6, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application
SOLANA BEACH, Calif., March 05, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) d ­­iseases, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations
This is the Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

How pharmacy teams battled the snow and won
Reflecting on the often heroic efforts pharmacists and their teams have made to help patients during the recent snow, RPS President Ash Soni said:“I’d like to say a very heart-felt thank (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA aprueba los cambios en la etiqueta para el medicamento anticonvulsivo Potiga (ezogabine) que describen el riesgo de anormalidades de la retina, p é rdida potencial de la visi ó n y decoloraci ó n de la piel
[15-06-2015] En base a las revisiones de informes adicionales de seguridad de pacientes tratados con el medicamento anticonvulsivo Potiga (erzogabine), la Administraci ó n de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en ingl é s) ha determinado que los riesgos potenciales de p é rdida de visi ó n debido a cambios en la pigmentaci ó n de la retina y decoloraci ó n de la piel pueden ser manejados adecuadamente siguiendo las recomendaciones actuales en la etiqueta de Potiga. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson ’ s disease drug entacapone
[10-26-2015] A Food and Drug Administration (FDA) safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson ’ s disease. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

Calling all entrepreneur pharmacists: apply here
Pharmacists who are developing clinical innovations and enterprises to improve patient care and support service redesign are being urged to apply to NHS England’s Clinical Entrepreneur Training (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

Viroptic (Trifluridine) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

Imfinzi (Durvalumab Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
Cambridge, Mass. – March 5, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the U.S. Food and Drug Administration (FDA) has accepted the submission of a New Drug Application (NDA) for prucalopride (also known as SHP555). Prucalopride is... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 5, 2018 Category: Drugs & Pharmacology Source Type: news

What are Indications for Allergen-specific Immunotherapy?
Discussion Allergen-specific immunotherapy (AIT) is a disease modifying treatment for allergic disease. Sometimes referred to as desensitization, the premise is to expose the patient to small but regular amounts of a specific antigen thereby building tolerance within the patient to the allergen. AIT is often underused because of safety concerns and lack of appropriately trained health care providers and facilities to safely carry out AIT treatment. There are 4 main AIT treatments options currently: SCIT – subcutaneous immunotherapy Allergen is injected into the subcutaneous skin “Shots are effective in treati...
Source: PediatricEducation.org - March 5, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

Mylan to Introduce Cimduo (lamivudine and tenofovir disoproxil fumarate) as a New Cost-Saving HIV Combination Treatment in the U.S.
HERTFORDSHIRE, England and PITTSBURGH, March 2, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will launch Cimduo, which was approved in February by the U.S. Food and Drug Administration (FDA).... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Mylan to Introduce Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate) as a New Cost-Saving HIV Combination Treatment in the U.S.
HERTFORDSHIRE, England and PITTSBURGH, March 2, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced that it will launch a new HIV treatment, Symfi Lo, which was approved in February by the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Bioanalytical Method Validation [Revised Final]
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Osmolex ER (Amantadine) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Thrombin-JMI (Thrombin Topical Bovine Origin) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Otonomy Announces FDA Approval of Otiprio (ciprofloxacin otic suspension) for Acute Otitis Externa
SAN DIEGO, March 02, 2018 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
DUBLIN, March 2, 2018 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with standard review the company's New Drug Application (NDA) seeking marketing... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2018 Category: Drugs & Pharmacology Source Type: news

Exondys 51 (Eteplirsen Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 1, 2018 Category: Drugs & Pharmacology Source Type: news