Drug Development Tool (DDT) Qualification Programs
Information about the mission and objectives of FDA ’s Drug Development Tool (DDT) qualification programs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 10, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Changes to our Regulations
The RPS Assembly have agreed that a number of amendments to ourRegulationswill be made. All changes are indicated in red and will take effect from 1 March. Members who wish to comment on these change (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 10, 2020 Category: Drugs & Pharmacology Source Type: news

Supply Disruption Alert - Phenytoin Sodium NRIM 100mg capsules (Accord)
Accord will be.... (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 10, 2020 Category: Drugs & Pharmacology Source Type: news

Review of DOACs and Guide for Effective Drug Utilization Review of DOACs and Guide for Effective Drug Utilization
This article reviews the pharmacology, indications, and contraindications of currently available direct oral anticoagulants, with a focus on selecting the appropriate DOACs in clinical practice.American Journal of Cardiovascular Drugs (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 10, 2020 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Cipro vs. Flagyl
Title: Cipro vs. FlagylCategory: MedicationsCreated: 10/3/2017 12:00:00 AMLast Editorial Review: 1/10/2020 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - January 10, 2020 Category: Drugs & Pharmacology Source Type: news

Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 10, 2020-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company has initiated a rolling submission of its New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 10, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Expands Use of Antifungal Micafungin (Mycamine) to Newborns FDA Expands Use of Antifungal Micafungin (Mycamine) to Newborns
The FDA has approved the use of micafungin sodium to treat invasive candidiasis in children younger than 4 months of age.FDA Approvals (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 10, 2020 Category: Drugs & Pharmacology Tags: Infectious Diseases News Alert Source Type: news

FDA approves avapritinib for gastrointestinal stromal tumor with a rare mutation
On January 9, 2020, FDA approved avapritinib (AYVAKITTM, Blueprint Medicines Corporation) for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 9, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors
FDA approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 9, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

IBD May Increase Risk for Adverse Pregnancy Outcomes
THURSDAY, Jan. 9, 2020 -- Women with inflammatory bowel disease (IBD) more often have gestational diabetes and preterm premature rupture of membranes, according to a review published online Jan. 7 in Alimentary Pharmacology and Therapeutics. Parul... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 9, 2020 Category: Pharmaceuticals Source Type: news

Report from coroner to prevent future deaths
Following the investigation and inquest into the death of a patient... (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 9, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor
CAMBRIDGE, Mass., Jan. 9, 2020 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 9, 2020 Category: Drugs & Pharmacology Source Type: news

Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC ( “Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all un (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse eve (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts - 559540 - 10/18/2018
Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts, 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 8, 2020 Category: Drugs & Pharmacology Authors: Office of Pharmaceutical Quality Operations, Division III Source Type: news

FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer
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 8, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Hormone Exposure and Risk for Dementia Later in Life Hormone Exposure and Risk for Dementia Later in Life
What does a woman's cumulative exposure to hormones mean for later cognitive health?Medscape Ob/Gyn (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 8, 2020 Category: Drugs & Pharmacology Tags: Ob/Gyn & Women ' s Health Commentary Source Type: news

Stopping Anti-TNF Therapy in Perianal Crohn's Disease Stopping Anti-TNF Therapy in Perianal Crohn's Disease
Does stopping anti-TNF therapy in patients with perianal Crohn's disease result in relapse?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 8, 2020 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Altafluor (Fluorescein Sodium and Benoxinate Ophthalmic Solution) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

Flurox (Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

July - September 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Signals of Serious Risks (FAERS) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Does inflammatory bowel disease carry certain risks during pregnancy?
(Wiley) Pregnant women with inflammatory bowel disease (IBD) are more likely to undergo delivery by Caesarean section and face certain risks during pregnancy, according to an analysis published in Alimentary Pharmacology& Therapeutics. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 8, 2020 Category: International Medicine & Public Health Source Type: news

FDA Approves Expanded Indication of Mycamine (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age
NORTHBROOK, Ill., Jan. 8, 2020 /PRNewswire/ -- Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection) in support of the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

Nabriva Therapeutics Receives FDA Acknowledgement of New Drug Application Resubmission for Intravenous Contepo (fosfomycin) for Injection
DUBLIN, Ireland, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
KENILWORTH, N.J.--(BUSINESS WIRE) January 8, 2020 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 8, 2020 Category: Drugs & Pharmacology Source Type: news

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 7, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Rulemaking History for OTC Topical Antimicrobial Drug Products
The Status of Over-the-Counter (OTC) Rulemakings contains the citation number of the Federal Register notices organized by therapeutic category subtopics. This rulemaking history webpage is intended as a research aid and is not an official FDA record. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 7, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Apollo Health And Beauty Care, Inc. - 593033 - 12/23/2019
CGMP/Finished Pharmaceuticals/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 7, 2020 Category: Drugs & Pharmacology Authors: Center for Drug Evaluation and Research Source Type: news

Balcoltra (Levonorgestrel and Ethinyl Estradiol and Ferrous Bisglycinate Tablets ) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 7, 2020 Category: Drugs & Pharmacology Source Type: news

FDA OKs Faster Aspart Insulin for Children With Diabetes FDA OKs Faster Aspart Insulin for Children With Diabetes
The formulation was initially approved in 2017 and was approved for insulin pump use in 2019.FDA Approvals (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 7, 2020 Category: Drugs & Pharmacology Tags: Diabetes & Endocrinology News Alert Source Type: news

FDA Approves Fiasp (insulin aspart injection) for the Treatment of Children with Diabetes
PLAINSBORO, N.J., Jan. 6, 2020 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.1... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 6, 2020 Category: Drugs & Pharmacology Source Type: news

Innovation in New Drug Approvals of 2019 Advances Patient Care Across a Broad Range of Diseases
In 2019, the FDA approved a wide variety of new drugs never before marketed in the United States, known as "novel" drugs, along with a range of new approvals containing active ingredients already on the market put to new and innovative uses. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

New Drug Therapy Approvals 2019
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 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FibrometerV2G vs. Enhanced Liver Fibrosis Score in NAFLD FibrometerV2G vs. Enhanced Liver Fibrosis Score in NAFLD
Do the Enhanced Liver Fibrosis score and the FibroMeterV2G have equal accuracy in the non-invasive diagnosis of advanced liver fibrosis in patients with NAFLD?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 6, 2020 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

2018 Meeting Materials, Gastrointestinal Drugs Advisory Committee
This page contains the meeting materials for the Gastrointestinal Drugs Advisory Committee meetings for 2018, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, and transcript. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

October 17, 2018: Gastrointestinal Drugs Advisory Committee Meeting Announcement - 10/17/2018 - 10/17/2018
October 17, 2018: Gastrointestinal Drugs Advisory Committee Meeting Announcement (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Prescription to Over-the-Counter (OTC) Switch List
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Duavee (Conjugated Estrogens and Bazedoxifene Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 6, 2020 Category: Drugs & Pharmacology Source Type: news

Otrexup PFS (Methotrexate Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 6, 2020 Category: Drugs & Pharmacology Source Type: news

Combination Products Performance Reports
Annual report to Congress on the activities and impact of the Office of Combination Products (OCP) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Option Care Enterprises, Inc. dba Option Care - 527394 - 12/20/2019
Drug Product/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Depo-SubQ Provera (Medroxyprogesterone Acetate) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 3, 2020 Category: Drugs & Pharmacology Source Type: news

CIS-Sulfur Colloid (CIS-Sulfur Colloid) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 3, 2020 Category: Drugs & Pharmacology Source Type: news

Zilretta (Triamcinolone Acetonide Extended-Release Injectable Suspension) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 3, 2020 Category: Drugs & Pharmacology Source Type: news

EluRyng (Etonogestrel and Ethinyl Estradiol Vaginal Ring) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 3, 2020 Category: Drugs & Pharmacology Source Type: news

An-Sulfur Colloid (Kit for Preparation of Technetium Tc99m Sulfur Colloid Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 3, 2020 Category: Drugs & Pharmacology Source Type: news

FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
Listen to an audio podcast of the December 19, 2019 FDA Drug Safety Communication warning that serious breathing difficulties may occur in patients using seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshot: ENHERTU
Treatment of adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Used in patients who have been previously treated for their metastatic disease with at least two anti-HER2 regimens. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Postmarketing Studies and Clinical Trials —Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
Guidance for Industry - Drug Safety (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news