Mallinckrodt Confirms Receipt of Stannsoporfin Complete Response Letter
STAINES-UPON-THAMES, United Kingdom, Aug. 22, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, confirmed today that it has received a Complete Response Letter from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 22, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Diacomit (stiripentol) for Seizures Associated with Dravet Syndrome
On August 20, 2018, the U.S. Food and Drug Administration (FDA) approved Diacomit (stiripentol) for seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. Dravet syndrome is a rare genetic condition that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 21, 2018 Category: Drugs & Pharmacology Source Type: news

Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application
DUBLIN, Aug. 21, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ulipristal acetate (UPA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 21, 2018 Category: Drugs & Pharmacology Source Type: news

Benzodiazepines vs. Ambien
Title: Benzodiazepines vs. AmbienCategory: MedicationsCreated: 8/21/2018 12:00:00 AMLast Editorial Review: 8/21/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - August 21, 2018 Category: Drugs & Pharmacology Source Type: news

Solodyn (Minocycline Hydrochloride) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 21, 2018 Category: Drugs & Pharmacology Source Type: news

Tong-Xie-Yao-Fang vs Placebo for Diarrhea-Predominant IBS Tong-Xie-Yao-Fang vs Placebo for Diarrhea-Predominant IBS
Might the Chinese herbal formula Tong-Xie-Yao-Fang be effective in controlling symptoms of IBS-D?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 21, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

FDA Approves Expanded Label for Merck ’s Keytruda (pembrolizumab) in Patients with Metastatic Nonsquamous NSCLC with No EGFR or ALK Genomic Tumor Aberrations
KENILWORTH, N.J.--(BUSINESS WIRE) August 20, 2018 --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 an expanded label for Keytruda, Merck ’s... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 21, 2018 Category: Drugs & Pharmacology Source Type: news

Etoposide Injection (Updated - Currently in Shortage)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - August 20, 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 - August 20, 2018 Category: Drugs & Pharmacology Source Type: news

Darifenacin Hydrobromide Tablets (New - Discontinuation)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - August 20, 2018 Category: Drugs & Pharmacology Source Type: news

Prednisolone Acetate 1% Ophthalmic Suspension (New - Discontinuation)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - August 20, 2018 Category: Drugs & Pharmacology Source Type: news

Company-led recall: Nutriflex Omega Special 2500ml
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company led recall for specific batches of Nutriflex Omega Special 2500ml (B. Braun Medical Ltd), because it has been identi (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - August 20, 2018 Category: Drugs & Pharmacology Source Type: news

Benzodiazepines vs. Cyclobenzaprine
Title: Benzodiazepines vs. CyclobenzaprineCategory: MedicationsCreated: 8/20/2018 12:00:00 AMLast Editorial Review: 8/20/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - August 20, 2018 Category: Drugs & Pharmacology Source Type: news

Primaxin IM (Imipenem and Cilastatin) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 20, 2018 Category: Drugs & Pharmacology Source Type: news

Primaxin I.V. (Imipenem and Cilastatin for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 20, 2018 Category: Drugs & Pharmacology Source Type: news

Synthetic Cannabinoid K2 Overdoses Are Rampant. Here's Why.
NIDA pharmacologist Michael Baumann explains how "unscrupulous vendors" hijacked compounds used in neuroscience and turned them into dangerous drugs. (Source: The Scientist)
Source: The Scientist - August 17, 2018 Category: Science Tags: News & Opinion Source Type: news

Metronidazole vs. Miconazole
Title: Metronidazole vs. MiconazoleCategory: MedicationsCreated: 8/17/2018 12:00:00 AMLast Editorial Review: 8/17/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - August 17, 2018 Category: Drugs & Pharmacology Source Type: news

Jornay PM (Methylphenidate Hydrochloride Extended-release Capsules ) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 17, 2018 Category: Drugs & Pharmacology Source Type: news

Sensorcaine (Bupivacaine HCI Injections) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular Degeneration
TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Eylea (aflibercept)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer
PRINCETON, N.J.--(BUSINESS WIRE)--August 17, 2018 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 17, 2018 Category: Drugs & Pharmacology Source Type: news

Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease
MUMBAI, India& PRINCETON, N.J.--(BUSINESS WIRE)-- August 16, 2018 -- Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715, “Sun Pharma” and includes its subsidiaries and/or associate companies)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Woodcliff Lake, NJ and Kenilworth, NJ, Aug. 16, 2018 – Eisai Inc. and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor Lenvima... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

RPS England champions pharmacists working with care homes to STPs
RPS England has been working to open doors for pharmacy by ensuringthe benefits the profession can bring are better understood within local and national NHS organisations. The third briefing in our s (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

Benzodiazepines vs. Barbiturates
Title: Benzodiazepines vs. BarbituratesCategory: MedicationsCreated: 8/16/2018 12:00:00 AMLast Editorial Review: 8/16/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

erythromycin (Ery-Tab, PCE)
Title: erythromycin (Ery-Tab, PCE)Category: MedicationsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 8/16/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

Arakoda (Tafenoquine Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

Annovera (Segesterone Acetate and Ethinyl Estradiol Vaginal System) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

SoluPrep (Film-Forming Sterile Surgical Solution) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

Onpattro (Patisiran Lipid Complex Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

Evoke Pharma ’s Gimoti NDA Accepted for FDA Review
SOLANA BEACH, Calif., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company ’s 505(b)(2) New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 16, 2018 Category: Drugs & Pharmacology Source Type: news

Fecal Transplant for Severe Refractory C. Difficile Infection Fecal Transplant for Severe Refractory C. Difficile Infection
This RCT compared the efficacy of two fecal microbiota transplant protocols associated with vancomycin in curing patients with severe Clostridium difficile infection refractory to antibiotics.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 16, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

RPS supports increased role of pharmacists in hospital discharge
A national review to evaluate the quality of hospital discharge in Wales has called for the introduction of ward-based pharmacists to help improve medication lists and the production of timely dischar (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

Soltamox (Tamoxifen Citrate) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

Tripedia (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

Nuvessa (Metronidazole Vaginal Gel) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

Poteligeo (Mogamulizumab-kpkc Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

NP-Thyroid (Thyroid Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

WP-Thyroid (Thyroid Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

Ortho Dermatologics Resubmits U.S. New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion
LAVAL, Quebec, Aug. 15, 2018 /PRNewswire/ -- Ortho Dermatologics, a division of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to & lt;24 Months with Certain Mutations in the CFTR Gene
BOSTON--(BUSINESS WIRE)--Aug. 15, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 15, 2018 Category: Drugs & Pharmacology Source Type: news

Ustekinumab for Crohn's Disease: Long-term Efficacy, Safety Ustekinumab for Crohn's Disease: Long-term Efficacy, Safety
This study assessed long-term extension data of ustekinumab for Crohn's disease, demonstrating the maintenance of response and remission and continued safety through 92 weeks.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 14, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections
NEW YORK, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food& Drug Administration (FDA) has accepted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 14, 2018 Category: Drugs & Pharmacology Source Type: news

Drug repurposing study sheds light on heart disease risk
(Brigham and Women's Hospital) A team led by researchers at Brigham and Women's Hospital has developed a computational technique to reveal the unknown side effects -- both good and bad -- of hundreds of drugs. That knowledge could help pharmacologists discover new indications for drugs already on the market and repurpose them for other disorders. Using their unique method, the researchers discovered that two drugs commonly prescribed for non-coronary disorders may affect heart disease risk. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 14, 2018 Category: International Medicine & Public Health Source Type: news

MHRA issues further information on valproate use by women and girls
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a video to help healthcare professionals in implementing the new 2018 regulatory measures, including the pregnancy prevention (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - August 13, 2018 Category: Drugs & Pharmacology Source Type: news

Nitrolingual Pumpspray (Nitroglycerin Lingual Spray) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters
Brussels (Belgium)& Atlanta Georgia, August 13th 07:00 (CEST): UCB today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for midazolam nasal spray*, an investigational product... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease
August 10, 2018 -- The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Annovera (segesterone acetate and ethinyl estradiol) Vaginal Contraceptive System
NEW YORK, Aug. 10, 2018 /PRNewswire/ -- The Population Council, a global nonprofit research organization, announced it has received U.S. Food and Drug Administration (FDA) approval for Annovera ™ (segesterone acetate and ethinyl estradiol vaginal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Onpattro (patisiran) Targeted RNA-based Therapy for Polyneuropathy Caused by hATTR
August 10, 2018 -- The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2018 Category: Drugs & Pharmacology Source Type: news