New products for pharmacists 09-10-2014


New Rx, indications, generics, and OTC

Rx Care, New drugs

BioCSL Inc. has begun shipping its seasonal influenza vaccine Afluria for the 2014-2015 flu season. The company plans to deliver about 16.5 million doses of the 2014-2015 formulation, of which approximately three-quarters will be in thimerosal-free prefilled syringes.  Approved with Afluria was PharmaJet’s Stratis 0.5mL Needle-Free Jet Injector, the first needle-free flu vaccine injector to receive FDA approval, for use with patients 18-64 years of age. ( ( (Image courtesy of PharmaJet)

FDA has approved the fixed-dose combination of abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg tablets (Triumeq; ViiV Healthcare) to treat HIV-1 infection. This is the first single-pill option to contain dolutegravir. A boxed warning notes hypersensitivity reactions, lactic acidosis and severe hepatomegaly, and exacerbations of hepatitis. See PI for complete list of contraindications and adverse reactions. (

FDA has approved the fixed-dose combination of the SGLT2 inhibitor canagliflozin with metformin hydrochloride (Invokamet; Janssen), in 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, or 150 mg/1,000 mg doses, to be taken twice daily as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who need treatment additional to either canagliflozin or metformin, or who already take both ingredients in separate formulations. A boxed warning cites lactic acidosis, and the product is accompanied by a Medication Guide. (

Also approved is empagliflozin (Jardiance), an SGLT2 inhibitor from Boehringer Ingelheim and Eli Lilly, in 10- or 25-mg doses, for once-daily use as an adjunct to diet and exercise to improve glycemic control or blood glucose levels in adults with type 2 diabetes. Patients with type 1 diabetes or diabetic ketoacidosis should not take empagliflozin.  (

Approved in April as an adjunctive therapy for patients with type 2 diabetes, albiglutide (Tanzeum), GlaxoSmithKline’s GLP-1 receptor agonist for once-weekly subcutaneous injection, is now available in pharmacies throughout the United States. (

A year after it turned down the manufacturer’s higher-dose version of the same product, FDA has approved suvorexant (Belsomra; Merck) to treat insomnia. An orexin receptor antagonist, it is the first agent of its class to receive approval. After taking one dose (5 mg minimum/20 mg maximum) within 30 minutes of bedtime, patient should remain in bed for at least seven hours. Suvorexant, a controlled substance, can cause sleep-driving and other partial-sleep behaviors, as well as impaired driving the following day. It is accompanied by a Medication Guide. (

FDA has approved GSK’s corticosteroid asthma treatment fluticasone furoate inhalation powder (Arnuity Ellipta), in 100- and 200-µg dry-powder doses for once-daily inhalation as a maintenance treatment in patients 12 years of age and older. This product is not indicated for relief of acute bronchospasm. The PI lists safety issues. (

FDA also  approved the once-daily olodaterol inhalation spray 5 µg (Striverdi Respimat; Boehringer Ingelheim) for long-term maintenance of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who experience airflow obstruction. It is not indicated to treat asthma or acuter deteriorations of COPD, and is dispensed with a Medication Guide. A boxed warning cites risk of asthma-related death. ( (Image courtesy of Boehringer Ingelheim)



New indications

FDA has approved diclofenac (Zorvolex; Iroko Pharmaceuticals), a nonsteroidal anti-inflammatory drug, in 35-mg capsules, for the management of osteoarthritis pain. The product design reflects an FDA call for treatments that use the lowest effective dose for as brief a period as possible. This is the product’s second indication, which FDA approved in October 2013 for mild-to-moderate acute pain in adults. ( (Image courtesy of Iroko Pharmaceuticals)

Regeneron has announced FDA approval of aflibercept injection (Eylea) to treat diabetic macular edema. Dosage is one 2-mg injection/month for five months, followed by a new injection every two months after that. Aflibercept was approved in the United States to treat neovascular (wet) age-related macular degeneration in 2011 and to treat macular edema following central retinal vein occlusion in 2012. ( (Image courtesy of Regeneron)

FDA has approved the oral anticoagulant drug apixaban (Eliquis; Bristol-Myers Squibb/Pfizer) for treating deep vein thrombosis and pulmonary embolism, and for preventing recurrences. Previously approved to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation, apixaban increases risk of bleeding, including possibly fatal hemorrhages. See PI for full safety information, boxed warning, and Medication Guide. (

Genentech has announced FDA approval of a new use for bevacizumab (Avastin) in combination with paclitaxel and cisplatin or paclitaxel and topotecan, to treat patients with persistent, recurrent, or late-stage (metastatic) cervical cancer. FDA noted that this “is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin” as well as being the first biologic agent approved for this indication. Since its first approval in 2004 to treat metastatic colon cancer, it has been approved to treat several other types of cancer. ( 

FDA has expanded its approval of alglucosidase alfa (Lumizyme; Genzyme) to include treatment of Pompe disease in patients of all ages and has terminated its risk mitigation strategy (REMS) requirements. Pompe disease causes gene mutations that prevent the body from making enough of an enzyme needed for proper muscle functioning. Original data were inadequate to support safety and efficacy in infantile-onset patients younger than 8 years of age; they have been treated with Myozyme, also made by Genentech. FDA now considers Myozyme and Lumizyme comparable. Lumizyme still carries a boxed warning that cites multiple issues. (

Janssen and Pharmacyclics have announced expanded approval of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy. FDA also approved ibrutinib for CLL patients with del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost. CLL patients with del 17p are considered to have the poorest prognosis, and ibrutinib is the first treatment to be approved specifically to treat these patients. Ibrutinib is dosed orally with three 140 mg capsules) once daily. For safety information and full dosing instructions, see the PI. (


New generics

Mylan has been first to launch potassium chloride extended-release tablets, USP in 600-mg and 750-mg dosage strengths, generic for Upsher-Smith’s Klor-Con. According to the company, it is used to treat patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. ( 

Amneal has launched four new generics, including acyclovir ointment, USP 5%. The generic is an AB-rated therapeutic equivalent to Valeant’s Zovirax Ointment 5%, used to treat certain viral infections including cold sores, shingles, and chickenpox. ( (Image courtesy of Amneal)

Amneal was first-to-market with atovaquone oral suspension, USP, 750 mg/5 mL strength, an AB-rated therapeutic equivalent to GSK’s Mepron Oral Suspension. The product is used to treat Pneumocystis carinii pneumonia, common among patients with compromised immune systems. ( (Image courtesy of Amneal)

Amneal also has launched clindamycin palmitate hydrochloride for oral solution, USP (Pediatric), an AA-rated therapeutic equivalent to Cleocin Pediatric (Pharmacia/Upjohn), in 75 mg/5 mL reconstituted strength. Mixing the powder with water provides 100 mL of a cherry-flavored solution. It should be used to treat only serious bacterial infections when less toxic antimicrobial agents are inappropriate, as it can lead to C. difficile and possibly fatal colitis. It is dispensed with a boxed warning. ( (Image courtesy of Amneal)

Amneal has launched oxycodone hydrochloride tablets, USP (C-II) in strengths of 5, 10, 15, 20, and 30 mg. The Amneal generic is AB-rated and therapeutically equivalent to Mallinkrodt’s Roxicodone, an immediate-release oral formulation used to treat moderate-to-severe pain. ( (Image courtesy of Amneal)

Winthrop/Sanofi U.S. has launched oxaliplatin injection, generic for its own branded product, Eloxatin, in 50- and 100-mg vials, for IV use with 5-fluorouracil and leucovorin to treat advanced colorectal cancer or as adjuvant treatment of stage III colon cancer in some patients. A boxed warning notes danger of severe allergic reaction and death. ( (Image courtey of Winthrop/Sanofi U.S.)

Lannett has signed an agreement with Symplmed for exclusive U.S. distribution rights to perindopril erbumine tablets, an authorized generic version of Aceon, an ACE inhibitor that treats high blood pressure and is used to reduce risk of heart attack in some patients. The tablets will be available in 2-, 4-, and 8-mg strengths. (

Glenmark announced the launch of its telmisartan tablets, a generic version of Boehringer Engelheim’s Micardis, in 20, 40, and 80 mg, for treatment of hypertension. Product has commenced shipping. (

Perrigo has launched azelastine hydrochloride nasal spray (0.15%), its generic version of Meda Pharmaceuticals’ Astepro, in association with Impax Labs. A press statement notes that “Perrigo and Impax continue to be in first-to-file Hatch Waxman patent litigation with Meda Pharmaceuticals Inc. in the United States District Court for the District of New Jersey.” Astepro is an antihistamine used to treat seasonal allergy in patients 12 years of age and older. (



Perrigo has also announced that it was the first to receive final FDA approval of its ANDA for ibuprofen and phenylephrine hydrochloride tablets, 200 mg/10 mg, the OTC store-brand equivalent of Advil Congestion Relief Tablets, 200 mg/10 mg, indicated to relieve sinus pressure, nasal swelling and congestion, and headache. Perrigo expects to start shipping the product before the commencement of the cough/cold/flu season. (

Pro-Phase Labs is marketing Cold-Eeze Plus Natural Multi-Symptom Relief QuickMelts, which the company says will treat symptoms of a cold while cutting its duration in half. The product is formulated with zinc gluconate, elderberry, agueweed, peppermint, myrrah, and licorice, said to relieve cold and flu symptoms such as cough, chest congestion, and sore throat. ( (Image courtesy of Pro-Phase Labs)

Europharma’s Terry Naturally brand has launched Clinical Iron

, featuring Ferrochel vegetable iron chelated to bisglycinate, an amino acid-based organic molecule. Ferrochel iron has been clinically studied for its oxygenating properties and is easily absorbed and non-constipating. According to the company, mineral co-factors, such as amino-acid-chelated forms of magnesium, zinc and copper, are included to help restore energy and stamina. ( (Image courtesy of Europharma) 

Folks tired of drinking their instant energy shots can try Energems, a 15-calorie chocolate supplement with B vitamins and caffeine, coated in a hard shell. The milk-chocolate-, mint-, or peanut-butter-flavored products come in new single-serve bags of three, offering the equivalent of one cup of strong coffee, or in boxes of nine. ( (Image courtesy of EnerGems)

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