Product updates for pharmacists 11-10-2015

November 10, 2015

New Rx, generics, OTC, devices, apps, and more.

New drugs

FDA has granted accelerated approval to Boehringer Ingelheim’s idarucizumab (Praxbind) 5-g injection, the first reversal agent for the company’s anticoagulant dabigatran (Pradaxa). Use is indicated for  emergency situations when there is a need to reverse dabigatran’s blood-thinning effects. Dabigatran reversal exposes patients to the risk of blood clots and stroke from their underlying disease (such as atrial fibrillation). Product labeling recommends that patients resume their anticoagulant therapy as soon as medically appropriate. (www.praxbind.com)

See also: Product updates for pharmacists 10-10-2015

Relypsa has announced FDA approval of patiromer for oral suspension (Veltassa), a potassium-binding agent that reverses hyperkalemia, a serious problem for many patients with acute or chronic kidney disease or heart failure. The product should not be used as an emergency treatment for life-threatening hyperkalemia as its onset of action is delayed. A boxed warning states that it binds many other orally administered drugs, which could decrease their absorption and reduce their effects. A Medication Guide must accompany the product. (www.veltassa.com)

FDA has approves Tris Pharma’s amphetamine extended-release oral suspension, CII (Dyanavel XR), said to be the only once-daily, extended-release amphetamine-based oral liquid approved to treat attention deficit/hyperactivity disorder in children six years of age and older. A Medication Guide and boxed warning cite potential for abuse and dependence. The product should become available in 2016. (www.trispharma.com)

New formulations

Endo Pharmaceuticals and Biodelivery Sciences have announced FDA approval of buccal buprenorphine HCl (Belbuca), a dissolving film patch that releases the Schedule III opioid buprenorphine when attached to the inside of the cheek. It is intended to treat chronic, severe, around-the clock pain that does not respond to other treatments.

VivlodexThe product is scheduled for U.S. launch in the first quarter of 2016 and will be available in seven dosage strengths. A boxed warning cites danger of addiction, abuse, and misuse; life-threatening respiratory depression; accidental exposure; and neonatal opioid withdrawal syndrome. (www.belbuca.com)

See also: Product updates for pharmacists 09-10-2015

Iroko Pharmaceuticals has announced FDA approval of meloxicam (Vivlodex) capsules, the first low-dose nonsteroidal anti-inflammatory drug (NSAID), available in 5-mg and 10-mg daily doses to manage osteoarthritis pain. NSAIDs should be used as briefly as possible and in the lowest possible doses, to minimize risk of adverse cardiovascular and gastrointestinal events events, as cited in the boxed warning. (www.iroko.com(Product image courtesy of Iroko Pharmaceuticals)

LEO Pharma has announced FDA approval of calcipotriene/betamethasone dipropionate foam 0.005%/0.064% (Enstilar), an alcohol-free topical spray foam formulated to treat adults with plaque psoriasis over large and small

Lonsurfbody areas. Once-daily applications can be made for up to four weeks. Patients should not use more than 60 g every four days. (www.enstilar.com)

FDA has approved trifluridine/tipiracil (Lonsurf; Taiho Oncology), to treat metastatic colorectal cancer in patients for whom certain other therapies have become ineffective. Lonsurf may cause a severe decrease in blood cell and platelet production; patients should be closely monitored. Women receiving this treatment should be warned of potential risks to fetuses and they should not breastfeed. (www.lonsurf.com(Product image courtesy of Tailho Oncology)

FDA has approved the treatment combination of ambrisentan (Letairis, Gilead Sciences) and tadalafil (Adcirca, Eli Lilly) for pulmonary arterial hypertension. Study findings indicated that when the combo was given as initial treatment, patients were less likely to experience disease progression or be hospitalized, and had more improvement in exercise ability than patients receiving either therapy alone. A boxed warning cites embryo-fetal toxicity. Ambrisentan carries a REMS. (www.ambitioncombination.com)

 

 

New generics

Montelukast sodium chewable tabletsCamber has launched montelukast sodium chewable tablets 4 mg and 5 mg, generic for Merck’s Singulair, indicated to treat chronic allergic rhinitis and asthma. (www.camberpharma.com) (Product image courtesy of Camber Pharmaceuticals)

Camber also has launched clopidogrel tablets 75 mg, generic for Plavix (Bristol-Myers Squibb/Sanofi), indicated to prevent blood clots after heart attack or stroke. (www.camberpharma.com)

Another new Camber launch is prampipexole dihydrochloride tablets, generic for Boehringer Ingelheim’s Mirapex, indicated to treat Parkinson’s disease and restless legs syndrome. It will be available in dosages of 0.125 mg, 0.25 mg, 0.5 mg 0.75 mg, 1 mg, and 1.5 mg. (www.camberpharma.com)

Impax Labs announced FDA approval of guanfacine extended-release tablets, generic for Shire’s Intuniv, indicated to treat attention deficit/hyperactivity disorder in children and adolescents ages six to 17. Dosage will be available in 1-mg, 2-mg, 3-mg, and 4-mg strengths. (www.impaxlabs.com)

Mylan has launched levoleucovorin calcium injection, generic for Spectrum’s Fusilev, which counteracts the effects of unintended overdose of folic acid antagonists following osteosarcoma treatment with methotrexate therapy. The product will be available in single-use vials in doses of 10 mg/mL, 175 mg/17.5 mL and 250 mg/25 mL. (www.mylan.com)

Paliperidone extended-release tablets, another recent Mylan launch, are generic for Janssen’s Invega, indicated to treat schizoaffective disorder and schizophrenia in adults and adolescents 12-17 years of age. The tablets will be available in dosage strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. (www.mylan.com)

Also from Mylan comes ampicillin and sulbactam injection, generic for Pfizer’s Unasyn and available in vials of 1.5 g and 3 g, indicated to treat gynecological, intra-abdominal, and other infections in skin and skin structures. (www.mylan.com)

Mylan has launched fluvastatin sodium extended-release tablets 80 mg. It’s the generic version of Novartis’ Lescol XL, indicated to treat patients with high cholesterol in combination with diet and exercise. (www.mylan.com)

Sandoz has launched its own fluvastatin sodium extended-release tablets 80 mg. (www.sandoz.com)

FDA has approved Aurobindo’s aripiprazole tablets, therapeutically equivalent to Otsuka’s Abilify, indicated to treat psychotic conditions such as schizophrenia and bipolar disorder. The tablets will be available in dosage strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. (www.aurobindo.com)

Aurobindo also has received final approval for tramadol hydrochloride extended-release tablets USP, Class IV, therapeutically equivalent to Valeant’s Ultram, in dosage strengths of 100 mg, 200 mg, and 300 mg, to treat moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. (www.aurobindo.com)

FDA has also approved Aurobindo’s gemfibrozil tablets 600 mg, generic for Pfizer’s Lopod, indicated to treat hyperlipidemia along with diet and exercise. (www.aurobindo.com)

Dutasteride tabletsTeva has announced an exclusive launch of dutasteride capsules 0.5 mg, generic for GlaxoSmithKline’s Avodart, indicated to treat symptoms of benign prostatic hyperplasia. (www.teva.com)

Greenstone has launched ethosuximide capsules 250 mg and oral solution 250 mg/5 mL, its authorized generic version of Pfizer’s Zarontin, indicated to treat epileptic seizures. (www.greenstonellc.com)

Winthrop/Sanofi US has announced the availability of leflunomide tablets, generic for Sanofi’s Arava, indicated to treat active moderate-to-severe rheumatoid arthritis in adults. A boxed warning cites potential for severe liver injury. (www.sanofi.us(Product image courtesy of Winthrop/Sanofi US)

Tris Pharma has announced FDA approval of hydrocodone polistirex and chlorpheniramine polistirex extended-release oral suspension, generic for UCB’s Tussionex, in 115-mL and 473-mL bottles, indicated to treat cough and upper respiratory symptoms of allergies and colds. (www.trispharma.com)

 

OTC

Curamin Headache FormulaTerry Naturally has launched Curamin Headache Formula, a supplement mix geared for occasional headaches that includes magnesium amino acid chelate and a bioactive form of vitamin B6. (www.europharmausa.com(Product image courtesy of Europharma USA)

New from Pharmax, HLC Multi Strain 50 probiotic capsules include 50 billion CFU from a combination of 15 different strains, including eight strains of Lactobacilli and six strains of Bifidobacteria, selected to support gastrointestinal and immune health. Live yeast cells provide additional microflora support. (www.seroyal.com(Product image courtesy of Pharmax)

Genestra Brands’ Methylation Support combines betaine, choline, and B vitamins in their physiologically active form to help support homocysteine metabolism. Homocysteine is an amino acid that can be further metabolized into methionine or cysteine. Normal homocysteine levels are necessary for the methylation of nucleic acids, protein, and lipids, as well as for protein production. (www.seroyal.com

New from Nordic Naturals is ProOmega 2000. Described as its most potent soft-gel formulation to date, it features a new formulation of omega-3 fish oil that is 80% concentrated and 90+% in triglyceride form, designed to supply superior potency and absorbability. (www.nordicnaturals.com)

Matrixx Initiatives has launched Zicam Total Immune, described as a brand-new dietary supplement and immune support product in two formulations. Total Immune Orange Burst Melts blend electrolytes, antioxidants, B vitamins,

Carmex Click Sticksand caffeine. Total Immune Berry Crystals target immune support and digestive health in a combination of probiotics, zinc, and B vitamins. (zicamimmune.com)

Carma Labs has launched a limited edition of Carmex Winter Mint Lip Balm Click Sticks, available in specially marked two-packs (buy one, get one free) and four-packs (buy three, get one free), combining the original Carmex lip balm with a winter mint stick. (www.mycarmex.com(Product image courtesy of Carma Labs)

New devices

p-linkEZ-RFID has launched p-link, a wireless, light-guided, Rx will-call system.  Using proprietary RFID technology, p-link improves put-away, retrieval, and return-to-stock procedures (“no more alphabetizing”), and can adapt to any pharmacy layout without the need to purchase new bags, bins, or shelving.   (www.ez-rfid.com(Product image courtesy of EZ-RFID)

Kaz USA has launched the Vicks SmartTemp wireless smartphone thermometer. Described as the first Bluetooth-enabled thermometer from a major brand, the device combines with a companion app for Android or Apple to track several children’s temperatures simultaneously; take notes on symptoms and medications; transmit data to healthcare providers, family, and others; and prompt the parent to provide care at designated intervals. (www.kaz.com)

NeuroMetrix, the maker of Quell wearable pain relief technology, has teamed up with Advantage Consumer Healthcare to expand distribution into drugstores and other merchandise outlets. FDA-cleared for treatment of chronic pain, the noninvasive nerve-stimulation technology is designed to provide relief for people with painful diabetic neuropathy and other neuropathic pain, such as sciatica, fibromyalgia, and osteoarthritis. It can be used during sleep as well as in the daytime, and can be programmed to suit user needs. (www.quellrelief.com)

New app

FLAVORx has launched a new iPhone app intended to help the medicine go down and increase adherence rates among children. Parents can select a medication and a flavor, and then scan for the closest pharmacy capable of supplying the product. The free app can be downloaded from the iTunes App Store. (www.flavorx.com)

New service

NeedyMeds acquired the website safeneedledisposal.org from the Coalition for Safe Needle Disposal and then redesigned and developed it into an extensive resource on proper disposal of needles and syringes. It includes information on regulations and disposal sites for all 50 states and lists more than 2,600 U.S. disposal sites for home-generated sharps. There is also a 9-5 EST hotline. (800-643-1643)