Table 1. New drugs approved by the US Food and Drug Administration (FDA): December 13, 2014 through January 18, 2015

Transcription

1 Hosp Pharm 2015;50(3): Thomas Land Publishers, Inc. doi: /hpj Current FDA-Related Drug Information Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals Danial E. Baker, PharmD, FASHP, FASCP * This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. January 18, 2015 Ceftolozane/tazobactam Zerbaxa (Cubist Pharmaceuticals) Piperacillin/tazobactam; ticarcillin-clavulanate Treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections Inhibition of cell wall synthesis (cephalosporin) and beta-lactamase inhibitor Nausea, diarrhea, headache, pyrexia Injection; ceftolozane 1 g/tazobactam 0.5 mg per vial Diclofenac sodium Dyloject (Javelin Pharms) Ketorolac Use in adults for the management of mild to moderate pain and management of moderate to severe pain alone or in combination with opioid analgesics. Inhibition of the cyclooxygenase (COX-1 and COX-2) pathways and inhibition of prostaglandin synthetase Nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia Injection; 37.5 mg/ml * Director, Drug Information Center, College of Pharmacy, Washington State University Spokane, PO Box 1495, Spokane, WA Volume 50, March 2015

2 Edoxaban Savaysa (Daiichi Sankyo) Apixaban, rivaroxaban, warfarin Reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial therapy with a parenteral anticoagulant Factor Xa inhibitor Bleeding, anemia, rash, abnormal liver function tests Tablet; 15, 30, and 60 mg Finafloxacin Xtoro (Alcon) Topical quinolones Treatment of acute otitis externa (swimmer s ear) Anti-infective Pruritis, nausea Otic suspension Ivermectin Soolantra (Galderma) Benzoyl peroxide combination, azelaic acid Treatment of inflammatory lesions of rosacea Unknown Skin burning sensation and skin irritation Topical cream; 1% Levodopa/carbidopa Duopa (AbbVie) Levodopa/carbidopa tablets Treatment of motor fluctuations in patients with advanced Parkinson s disease Decarboxylation inhibitor Nausea, depression, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, and incision site erythema Enteral suspension; 4.63 mg carbidopa & 20 mg levodopa per ml Liraglutide Saxenda (Novo Nordisk) Liraglutide Treatment of obesity; adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (body mass index [BMI] 30 kg/m 2 ) or who are overweight (BMI 27 kg/m 2 ) with at least one weight-related comorbidity such as type 2 diabetes and cardiovascular disease Glucagon-like peptide-1 analogue Hospital Pharmacy 239

3 Nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase Solution for subcutaneous injection; 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg Memantine/Donepezil Namzaric (Forest Laboratories) Individual agents Treatment of moderate to severe Alzheimer s-related dementia in patients receiving stable doses of the two drugs N-methyl-D-aspartate inhibitor and acetylcholinesterase inhibitor Headache, diarrhea, and dizziness Capsule; 28/10 mg (memantine/donepezil) and 14/10 mg Nivolumab Opdivo (Bristol-Myers Squibb) Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor Human programmed death receptor-1 (PD-1) blocking antibody Rash Injection; 400 mg/4 ml, 100 mg/10 ml vials Olaparib Lynparza (AstraZeneca) Treatment of women with advanced ovarian cancer associated with defective BRCA genes Poly ADP-ribose polymerase (PARP) inhibitor Nausea, fatigue, vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite, nasopharyngitis, arthralgia, musculoskeletal pain, myalgia, back pain, dermatitis, and abdominal pain Capsules; 50 mg Ombitasvir, paritaprevir, ritonavir, and dasabuvir Viekira (AbbVie) Ledipasvir plus sofosbuvir; simeprevir plus sofosbuvir Treatment of patients, with or without compensated cirrhosis, with chronic hepatitis C virus genotype 1 infection NS5A inhibitor; NS3/4A protease inhibitor; CYP3A inhibitor; non-nucleoside NS5B palm polymerase inhibitor Fatigue, nausea, pruritus, skin reactions, insomnia, asthenia Two tablets; fixed dose combination tablet containing ombitasvir 12.5 mg, paritaprevir 75 mg, and ritonavir 50 mg and tablet containing dasabuvir 250 mg Volume 50, March 2015

4 Peramivir Rapivab (BioCryst) Oseltamivir, zanamivir Treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days Neuraminidase inhibitor Diarrhea Injection: 200 mg vial Table 2. New dosage forms and indications approved by the FDA: December 13, 2014 through January 18, 2015 Brand name Indication and comments New dosage forms/strength/route of administration Beclomethasone dipropionate Qnasl (Teva) New strength (40 mcg/spray) and new indication for the treatment of nasal symptoms of allergic rhinitis for children between 4 and 11 years old Carbidopa/levodopa Influenza vaccine Pasireotide New indications Lanreotide Rytary (Impax Labs) Fluzone intradermal quadrivalent vaccine (Sanofi Pasteur) Signifor LAR (Novartis) Somatuline depot injection (Ipsen Pharma) Extended-release capsule; 23.75/95, 36.25/145, 48.75/195, mg/245 mg New quadrivalent to provide protection against 4 strains of influenza virus instead of 3 Long-acting release formulation for intramuscular injection for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option Treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival Table 3. Agents pending FDA approval: December 13, 2014 through January 18, 2015 Brand name Indication and comments Complete response letter: More information required Nebivolol/valsartan (Actavis) Cardiovascular and Renal Drugs Advisory Committee voted against approval in October Hospital Pharmacy 241

5 Table 4. New drug/biologics license applications filed by manufacturer: December 13, 2014 through January 18, 2015 Brand name Comparative agents Indication Mechanism of action Common adverse effects Dosage form or route Cobimetinib (Roche) Recombinant factor VIII (BAY ) Factor VIII Used in combination with vemurafenib for patients with BRAF V600 mutationpositive advanced melanoma Treatment of hemophilia A in adults and children Antagonist of mitogen-activated protein kinase (MEK); a protein inside cancer cells that is involved with the signaling pathway that regulates cell division and survival Replacement factor Diarrhea, nausea, rash, photosensitivity and increases in liver function test and elevated creatine phosphokinase Facial flushing, headache, nausea, injection site reactions Oral Injection 242 Volume 50, March 2015