New Products

NEW Rx

Image courtesy of GlaxoSmithKlineFDA has granted accelerated approval to GlaxoSmithKline for the combination use of trametinib  (Mekinist) and dabrafenib (Tafinlar), a first-ever two-drug regimen for treatment of melanoma. These drugs are used as oral targeted therapies for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, at least one of which is present in half of all newly diagnosed melanomas. The approval remains contingent on the results of an ongoing phase III clinical trial comparing the dabrafenib-trametinib combination and dabrafenib-placebo as first-line therapy for patients with metastatic or unresectable melanoma. Trametinib in combination with dabrafenib can cause serious side effects, some of which can be life-threatening. Complete lists of adverse reactions can be found at the trametinib and dabrafenib websites, along with a patient information leaflet for trametinib and a Medication Guide for dabrafenib. GSK offers an assistance program (866-265-6491) for eligible patients who need Tafinlar and Mekinist therapy. (http://bit.ly/mekinistPI; http://bit.ly/tafinlarPI)

In January, AstraZeneca and Bristol-Myers Squibb announced FDA approval of dapagliflozin (Farxiga) once-daily tablets for adult use as an adjunct to diet and exercise in the treatment of  type 2 diabetes. The recommended starting dose of 5 mg, taken in the morning, with or without food, can be increased to 10 mg once daily. Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c. Patients with type 1 diabetes, diabetic ketoacidosis, or active bladder cancer should not take dapagliflozin. In clinical trials, the most common side effects reported by patients were genital mycotic (fungal) infections and urinary tract infections. FDA is requiring six post-marketing studies for Farxiga. (http://www.farxiga.com)

Takeda and Lundbeck announced in January that vortioxetine (Brintellix), a treatment of adult major depressive disorder that received FDA approval September 30, 2013, is now available in pharmacies. For more information, see February’s New Drug Review (page 62). (http://us.brintellix.com)

Nuvo Research announced in mid-January that FDA had approved diclofenac sodium topical solution 2% (Pennsaid) to treat pain associated with osteoarthritis of the knee. It is the first 2% product to be approved for that purpose. The original Pennsaid 1.5% has been available in the United States since 2010. Mallinckrodt will market both products. (http://www.pennsaid.com)

New generics

Image courtesy of AmnealAMNEAL has announced the launch of esomeprazole strontium 49.3 mg delayed-release capsules, an authorized generic for the branded product launched by Amneal in December 2013. Esomeprazole strontium is a proton pump inhibitor indicated for short-term use in adults for the treatment of gastroesophageal reflux disease (GERD), NSAID-associated gastric ulcer risk, H. pylori eradication, and risk reduction of duodenal ulcer recurrence, as well as treatment of pathological hypersecretory conditions. Each capsule provides the equivalent of 40 mg of esomeprazole, the same amount of esomeprazole that is present in AstraZeneca’s 40 mg Nexium capsule, but in a different salt form. According to Amneal, esomeprazole strontium 49.3 mg presents a potentially more affordable treatment option for GERD in adult patients. Esomeprazole strontium is not recommended for use by patients with severe renal impairment. Nursing mothers should consider discontinuing esomeprazole strontium. For a complete list of adverse effects and safety information, see the prescribing information. The product began shipping early in January. (http://amneal.com/esomep/pi.pdf)

Image courtesy of Greenstone LLCGreenstone LLC, a U.S.-based generic pharmaceutical subsidiary of Pfizer, has announced the launch of Sirolimus 0.5 mg, an authorized generic version of Pfizer’s Rapamune, indicated for the prophylaxis of organ rejection in patients 13 years of age or older receiving renal transplants. The product carries a black-box warning for its immunosuppressive activity; its use by liver- or lung-transplant patients is not recommended. See the PI for adverse events and contraindications. (www.greenstonellc.com/product-list.aspx)

In January, Mylan launched mycophenolic acid delayed-release tablets, 180 mg and 360 mg (generic for Novartis' Myfortic), to be used in combination with cyclosporine and corticosteroids as prophylaxis for organ rejection in adult patients receiving a kidney transplant and in pediatric patients five years of age and older who are at least six months post-kidney transplant. The products carry a black-box warning for embryofetal toxicity, malignancies, and serious infections, and include a Medication Guide. For a complete list of contraindications, adverse effects, and drug interactions, see the PI. (http://bit.ly/mycophenPI)

Par Pharmaceutical has begun shipping digoxin tablets, its authorized generic version of Covis Pharmaceutical’s Lanoxin, in 0.125 mg and 0.25 mg dosage strengths. Digoxin tablets are indicated for treatment of mild-to-moderate heart failure in adults; increasing myocardial contractility in pediatric patients with heart failure; and control of resting ventricular rate in adult patients with chronic atrial fibrillation. Digoxin tablets are contraindicated for patients with ventricular fibrillation and patients with hypersensitivity to digoxin (reactions seen include unexplained rash; swelling of the mouth, lips, or throat; difficulty breathing). If patients are hypersensitive to other digitalis preparations, digoxin is probably contraindicated. See the PI for full prescribing information. (http://www.parpharm.com)

On January 8, Actavis/Watson received FDA approval and 180 days market exclusivity for its abbreviated new drug application for generic telmisartan 20 mg, 40 mg, and 80 mg tablets. This product is an A-rated generic equivalent to Boehringer Ingelheim’s Micardis, an angiotensin II receptor blocker used to treat hypertension. It is also used to reduce risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older who cannot take ACE inhibitors and are at high risk (www.actavis.com). Also on January 8, Roxane Laboratories announced the launch of its authorized generic telmisartan (www.roxane.com). In addition, on January 8, both Torrent and Lupin Pharmaceuticals received FDA approval for their ANDAs for the combination of telmisartan and the calcium channel blocker amlodipine (generic for Boehringer Ingelheim’s Twynsta) in the following strengths (telmisartan/amlodipine): 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg. Lupin launched immediately; Torrent’s plans have not been announced (http://www.lupinpharmaceuticals.com; www.torrentpharma.com).

NEW OTC

Image courtesy of STS HealthFluNada, a new homeopathic cold and flu remedy from STS health, is available in more than 5,000 retail pharmacies this flu season. According to the company, the product, a throat and nasal spray formulated to inhibit virus replication, is the only remedy for treatment of cold and flu-like symptoms that coats both the throat and nasal pathways, where most viruses enter the body. The nondrowsy formula contains natural ingredients for relief of runny or blocked nose, sore throat, cough, and body aches and pains associated with the cold and flu. Laboratory tests showed FluNada to have >99.9% efficacy against multiple common cold and flu viruses within five minutes. Ingredients in the zinc-free include elderberry, mint, eucalyptus, and gaultheria, which are registered with the Homeopathic Pharmacopeia and recognized by FDA. Locations carrying the product include Walgreens, Duane Reade, Kerr Drug, Harris Teeter, Winn Dixie, Bi-Lo, Food City, and Kinney Drug. It is also available online through Amazon.com, Walgreens.com, and drugstore.com. (www.STSHealth.com)

Image courtesy of Zarbee's NaturalsZarbee’s Naturals has launched three new cough syrups for children. Baby Cough Syrup is made with agave syrup instead of honey to eliminate bacterial issues for babies – making it the only product on the market, the company says, that can be safely administered to infants as young as two months. Children’s Nighttime Cough Syrup contains .5mg of plant-sourced melatonin to promote peaceful sleep for children as young as two years of age. Cough Syrup + Mucus Relief uses ivy leaf extract to help thin mucus and relax throat muscles of children struggling with wet coughs. (http://www.zarbees.com)

Image courtesy of Nordic NaturalsNordic Naturals’ new Tropical Mango Omega Boost delivers 525 mg of omega-3 fatty acids EPA and DHA in a formulation that can be dosed by teaspoon or added to a smoothie. Omega-3s support healthy heart, brain, and mood functions, and fortify the immune system. Derived from the purified oil of sardines and anchovies, the product is sugar-free and has been third-party tested for environmental toxins, including heavy metals such as mercury, dioxins, and PCBs. All fish oils used in Nordic Naturals products are in the triglyceride form and “surpass the strictest international standards for purity and freshness.” The company offers certificates of analysis upon request. (http://www.nordicnaturals.com)