* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download NEWS YOU CAN USE 2015 06 UPD
Drug interaction wikipedia , lookup
Drug discovery wikipedia , lookup
Drug design wikipedia , lookup
Epinephrine autoinjector wikipedia , lookup
Adherence (medicine) wikipedia , lookup
Neuropharmacology wikipedia , lookup
Pharmacokinetics wikipedia , lookup
Bevacizumab wikipedia , lookup
Orphan drug wikipedia , lookup
Compounding wikipedia , lookup
Prescription drug prices in the United States wikipedia , lookup
Theralizumab wikipedia , lookup
Prescription costs wikipedia , lookup
Pharmaceutical industry wikipedia , lookup
Pharmacogenomics wikipedia , lookup
New England Compounding Center meningitis outbreak wikipedia , lookup
List of off-label promotion pharmaceutical settlements wikipedia , lookup
News You Can Use… Pete Koval, PharmD Michael Rollins, PharmD Candidate Cone Health Family Medicine June 2015 New Drug Approval • Invega Trinza, a quarterly intramuscular injection formulation of paliperidone gained FDA approval for the treatment of schizophrenia • Paliperidone is currently formulated as a oncedaily tablet (Invega) and as a once-monthly injection (Invega Sustenna). • Before patients begin quarterly injections, they must first receive monthly injections for at least 4 months. 05/19/2015 Medscape New Drug Approval • Stiolto Respimat (tiotropium/olodaterol), a once daily inhaler, has been approved by the FDA for maintenance treatment of airflow obstruction in COPD. • Each actuation contains 2.5 mcg tiotropium and 2.5 mcg olodaterol. • It is administered as 2 inhalations at the same time each day • Common side effects include nasopharyngitis, cough, and back pain. 05/25/2015 FDA News and Events New Drug Approval • Humalog U-200 Kwikpen (insulin lispro): FDA approves new 200 unit/mL formulation indicated for improvement in glycemic control for type I and type II diabetes • Humalog U-200 holds 600 units per pen compared to 300 units in the Humalog U-100 formulation. 05/27/2015 Pharmacy Times Drug Launched • Namzaric (memantine/donepezil), a fixed dose combination approved for treatment of moderate-severe dementia in Alzheimer’s disease, is now available • Available in 14/10 mg (memantine/donepezil) and 28/10 mg strengths • Capsules can be opened and sprinkled onto food for patients that have difficulty swallowing 05/20/2015 Pharmacy Times New Indication • Treximet (sumatriptan/naproxen), has been approved by the FDA for treatment of migraines with or without aura in pediatric patients 12 years of age or older. • Previously was only indicated for adults aged 18+. • Starting dose for pediatric patients is 10/60 mg (sumatriptan/naproxen sodium) daily with a max dose of 85/500 mg daily. 05/15/2015 FDA News and Events New Drug Indication • Viberzi (eluxadoline) and Xifaxan (rifaximin), both have received FDA approval for treatment of Irritable Bowel Syndrome with diarrhea (IBS-D). • Side effects from eluxadoline are nausea, constipation and abdominal pain • Side effects from rifaximin are increased ALT and nausea • Eluxadoline is dosed 75 mg or 100 mg twice daily with food. • Rifaximin is dosed 550 mg three times daily for 14 days. Patients can be retreated twice with same regimen. 05/25/2015 FDA News and Events Generic Launched • The generic form of Seasonale, levonorgestrel and ethinyl estradiol, 0.15 mg/0.03 mg, is now available. • Seasonale is an extended cycle birth control form that contains 84 active pills and 7 inactive pills. 05/05/2015 Pharmacy Times Orphan Drug Designation • Humira (adalimumab), has been granted orphan status by the FDA to treat moderate-to-severe hidradenitis suppurativa • Hidradenitis suppurativa, or “acne inversa” is a painful, chronic inflammatory skin disease for which there is no known cure and no approved medication. 05/18/2015 Pharmaceutical Business Review