If you're having trouble viewing this email, you may see it online. Share this: Collaboration Connection A comprehensive monthly summary of the latest drug information directly from the FDA and tailored specifically for you Belmont University Drug Information Center Customers! Issue 22 June 2015 Genevieve Lynn Ness, Pharm.D. Editor Webinars New Drug Approvals 1. Continuing Education Webinar Series: June 25, 2015 from 12:00 pm–1:00 pm (EST) “Medication Errors: A CDER Perspective”. Additional details regarding this webinar will be forthcoming in a separate email. Register Here. 2. June 23, 2015 at 1pm (EST) “Introducing the REMS@FDA Website.” The featured speakers, Adam Kroetsch, MSPPM (Office of Strategic Programs) and LCDR Amy Ramanadham, PharmD, MS (Office of Center Director) will introduce REMS@FDA, FDA’s new REMS website. The REMS@FDA will launch June 15th. The Viberzi (eluxadoline) for adults for the treatment of irritable bowel syndrome with diarrhea (IBSD) Kybella (deoxycholic acid) treatment for adults with moderatetosevere fat below the chin, known as submental fat Invega Trinza (paliperidone palmitate) extendedrelease injectable suspension for the treatment of schizophrenia in adult patients who have been adequately treated with the 1month paliperidone palmitate injectable product for at least four months Rapamune (sirolimus) to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily speakers will demonstrate its new features and show how to navigate the site. Register Here. What's New 1. From our perspective: The U.S. drug supply chain and patient safety 2. FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs 3. From our perspective: Evaluating the changing landscape of health care antiseptics affects women of childbearing age Stiolto Respimat (tiotropium bromide and olodaterol) inhalation spray for oncedaily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended release oral suspension for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older First Generic Drug Appovals New Indications Avelox (moxifloxacin) for treatment of pneumonic plague (lung infection) and septicemic plague (blood infection), as well as the prevention of plague in adults Treximet (sumatriptan/naproxen) for the acute treatment of migraine with or without aura in adolescents 12 to 17 years old Xifaxan (rifaximin) for the treatment of irritable bowel syndrome with diarrhea (IBS D) in adults New Dosing Recommendations Alosetron hydrochloride AB rated to Lotronex Linezolid AB rated to Zyvox Recalls Teva Parenteral Medicines issues voluntary recall of select lots of Adrucil (fluorouracil injection, USP) 5g/100ml (50mg/ml) due to particulate matter A listing of all recalls can be found in the Enforcement Reports. Drug Safety Communications Breo Ellipta (fluticasone/vilanterol) the daily FDA Drug Safety Podcast: FDA cautions treatment of asthma in patients aged 18 about dose confusion and medication errors years and older and the addition of a 200 for antibacterial drug Zerbaxa (ceftolozane mcg/25mcg product and tazobactam) Lamictal (lamotrigine) the addition of FDA warns that SGLT2 inhibitors for pediatric safety information derived from a diabetes may result in a serious condition of maintenance treatment study of Bipolar I too much acid in the blood Disorder to delay the time to occurrence of mood episodes (depression, mania, Drug Safety Podcasts are also available. hypomania, mixed episodes) in patients (≥ 13 years of age) treated for acute mood episodes with standard therapy Dietary Supplements Weight Loss Products Containing Sibutramine New Medication Guides (May 2015): Medication Guide Webpage Slim Forte Slimming Capsule Li Da Dai Dai Hua Slimming Capsule Sexual Enhancer Products Containing Sildenafil Vogelxo (testosterone) Black Panther Viagra 007 King of Romance Drug Shortages Current Drug Shortages Pain Products Containing Drug Ingredients New: Calcium chloride injection, USP, Chloroquine phosphate tablets, Gemifloxacin Mesylate (Factive) Tablets, Imipenem and Cilastatin for Injection Resolved: Dimercaprol (BalinOil) injection, fluorescein sodium injection, Selenium Injection, Methylene Blue Injection, Nalbuphine hydrochloride (Nubain) injection, Sodium phosphate injection, Trypan blue (Membraneblue), irrigation solutions, sterile water for injection solutions, Radium RA223 dichloride (Xofigo) injection Ginseng She Lian Wan contains dexamethasone and chlorpheniramine Jianbu Huqian Wan contains dexamethasone, chlorpheniramine, and furosemide Asihuri Plus Forte contains dexamethasone and phenylbutazone Saurean Fong Sep Lin contains dexamethasone and cyproheptadine Questions or comments? Contact the Christy Houston Foundation Drug Information Center at: [email protected] or 6154608382 1900 Belmont Boulevard, Nashville, TN 37212 615.460.6748 | WWW.BELMONT. EDU This email was sent to [email protected]. To ensure that you continue receiving our emails, please add us to your address book or safe list. manage your preferences | opt out using TrueRemove®. Got this as a forward? Sign up to receive our future emails.