New products for pharmacists 05-10-2015


New Rx approvals, new launches, new indications, new formulation, new dosage strengths, new biosimilar, new generics, new OTC

Rx Care

New approvals

CorlanorRamucirumab (Cyramza; Eli Lilly), used in combination with Folfiri for metastatic  colorectal cancer progression after first-line treatment. A boxed warning notes increased risk of hemorrhage, including severe and sometimes fatal events. (

Ivabradine (Corlanor; Amgen), 5 mg and 7.5 mg tablets, to reduce risk of hospitalization in cases of worsening heart failure. Said to be the first new drug therapy in a decade to treat chronic heart failure. A Medication Guide accompanies this drug. ( (Product image courtesy of Amgen)

Isavuconazonium sulfate (Cresemba; Astellas Pharma), an antifungal treatment in oral and intravenous forms for adults with invasive aspergillosis and invasive mucormycosis. It is the sixth product to receive Qualified Infectious Disease Product (QIDP) designation for treatment of serious or life-threatening infections. (

Atazanavir/cobicistat (Evotaz; Bristol-Myers Squibb) 300 mg/100 mg, a fixed-dose combination for use with other antiretrovirals to treat HIV-1 in adults. (

Darunavir/cobicistat (Prezcobix; Janssen) 800 mg/150 mg, a fixed-dose combination for use with other antiretrovirals to treat HIV-1 in adults. (

Approved in the same week, both Prezcobix and Evotaz combine protease inhibitors with Gilead’s pharmacokinetic booster cobiscistat (Tybost). The companies say that fewer daily pills will make daily medication adherence easier.

New launches

Ceftazidime-avibactam (Avycaz; Actavis), indicated to treat complicated intra-abdominal infections and complicated urinary tract infections. Clinical and safety treatment data are limited; use should be confined to patients with few or no treatment options. Now available for ordering by U.S. hospitals. (

Edoxaban (Savaysa; Daiichi Sankyo), an anticoagulant approved by the FDA on Jan. 8, is now commercially available in the United States. The oral, once-daily factor Xa inhibitor should follow five to 10 days of initial therapy with a parenteral anticoagulant and does not require blood-monitoring. (

LilettaLiraglutide 3 mg (Saxenda injection; Novo Nordisk), the first GLP-1 receptor agonist to win U.S., E.U., and Canadian approval for chronic weight management in adults. It launched at the end of April. (

ProAir RespiClickLevonorgestrel-releasing intrauterine system 52 mg (Liletta; Actavis/Medicines 360), an IUD now available in the U.S. for use by women to prevent pregnancy for up to three years. ( (Product image courtesy of Actavis)

Albuterol sulfate inhalation powder  (ProAir RespiClick; Teva Respiratory), a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist inhaler to treat or prevent bronchospasm in patients 12 years of age and older with reversible obstructive airway disease. ( (Product image courtesy of Teva)


New indications

Nivolumab (Opdivo; Bristol-Myers Squibb), previously approved to treat advanced melanoma, now approved to treat non-small-cell lung cancer. (

Aflibercept injection (Eylea; Regeneron), for diabetic retinopathy in patients with diabetic macular edema, its fourth approval to treat an eye-related condition. (

Lenalidomide (Revlimid; Celgene) capsules 25 mg, previously approved to treat multiple myeloma patients who had received at least one therapy, now approved for newly diagnosed patients. Also previously approved to treat myelodysplastic syndromes and mantle cell lymphoma when disease has progressed after two previous therapies. (

Lisdexamfetamine dimesylate (Vyvanse; Shire), newly approved for adult binge-eating disorder, was approved in 2007 to treat ADHD. (

JadenuNew formulation

Deferasirox (Jadenu; Novartis), a new formulation of Exjade; a once-daily oral chelation tablet that simplifies daily treatment for patients with chronic iron overload, which affects people with sickle cell disease, thalassemia, and myelodysplastic syndromes. ( (Product image courtesy of Novartis)

New dosage strengths

Fentanyl transdermal system (Mylan) for management of pain in opioid-tolerant patients; “first and only” system available in intermediate strengths of 37.5 mcg/hr, 62.5 mcg/hr, 87.5 mcg/hr. (

Lisdexamfetamine dimesylate (Vyvanse; Shire), for treatment of ADHD, now available in 10 mg capsules as well as previous dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. (

Buprenorphine/naloxone (Zubsolv; Orexo) sublingual tablets for maintenance treatment of opioid dependence; new dosage of 8.6 mg/2.1 mg joins existing strengths of 5.7 mg/1.4 mg and 1.4 mg/0.36 mg. (

New biosimilar

Filgrastim-sndz (Zarxio; Sandoz), the first biosimilar approved in the United States; therapeutically similar to Amgen’s Neupogen, for treatment of patients receiving chemotherapy for certain cancers or patients with severe chronic neutropenia. (

Amlodipine/ValsartanNew generics

Amlodipine/valsartan tablets, Teva’s generic version of Novartis’ Exforge to treat hypertension, available in four strengths: 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg. (

Sandoz has launched the authorized generic version of Novartis’ Exforge (amlodipine/valsartan) tablets, in the same strengths as those provided by the branded drug: 5 mg/160 mg, 5 mg/320 mg, 10 mg/160 mg, and10 mg/320 mg. (

Salese lozengesOTC

Salese Lozenges (Nuvora), described by the maker as “the first technology for the long-lasting treatment of dry mouth.” Said to last up to several hours, significantly longer than typical treatments, the lozenges treat the oral cavity with a controlled release of substantially lower therapeutic doses of natural active ingredients. According to the manufacturer, the natural ingredients in Salese relieve dry mouth, kill plaque bacteria with xylitol and essential oils, neutralize acids from bacteria that cause cavities, and freshen breath, using zinc to capture volatile sulfur compounds from bacteria that cause bad breath. ( (Product image courtesy of Nuvora)

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