New Products for Pharmacists 12-10-2014


New Rx, new indications, new generics, new OTC

New drugs

Boehringer Ingelheim has announced that nintedanib (Ofev), approved in October to treat idiopathic pulmonary fibrosis (IPF), is now available in 100-mg and 150-mg dosage strengths in certain U.S. pharmacies. The only kinase inhibitor approved to treat IPF, nintedanib is one of only two medications in the country specifically designed to treat this disease. (

FDA has approved hydrocodone bitartrate (Hysingla ER; Purdue Pharma), an extended-release opioid analgesic with abuse-deterrent properties, to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. FDA has called for a boxed warning, post-marketing studies, a Risk Evaluation and Mitigation Strategy (REMS), and a Medication Guide. (

Reversing its decision made last December, FDA has approved alemtuzumab (Lemtrada; Genzyme/Sanofi) to treat patients with relapsing forms of multiple sclerosis (MS). The product is accompanied by a boxed warning and is available under a REMS program. Its use is appropriate for patients who have shown an inadequate response to two or more MS drug therapies. (

FDA also recently approved AstraZeneca’s combination therapy dapagliflozin and metformin hydrochloride
(Xigduo) for treatment of type 2 diabetes in adults, making it the first and only once-daily combination tablet composed of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. Several dosage strengths are available, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg. (

Salix and Pharming Group NV have announced the launch of their C1 esterase inhibitor [recombinant] (Ruconest) 50 IU/kg for treatment of acute attacks in adult and adolescent patients with hereditary angioedema, characterized by rapid swelling in various parts of the body, including the hands, feet, face, and abdomen. The product is not a plasma derivative. Comprehensive patient support services are available through the website or by calling 855-613-4HAE. (

Arbor Pharmaceuticals has announced FDA approval of its sotalol hydrochloride oral solution (Sotylize), indicated to treat life-threatening ventricular arrhythmias and to maintain normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter. This product is the first and only sotalol oral solution for treatment of this condition; it was previously available only in tablet form. It is accompanied by a boxed warning describing the risk of life-threatening ventricular tachycardia associated with QT prolongation. (

FDA has granted accelerated approval to Wyeth’s Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age, basing its approval upon patients’ immune response to four group B strains. Trumenba was also granted breakthrough therapy status, designed to expedite the development and review of therapies addressing a serious or life-threatening condition. Wyeth, a subsidiary of Pfizer, will conduct additional studies to verify Trumenba’s effectiveness against additional strains of serogroup B. According to FDA, vaccination is the most effective way to prevent meningococcal disease. (


New indications

Protein Sciences’ recombinant influenza vaccine (Flublok) is now approved to treat all adults 18 years of age and older. Flublok is the only 100% egg-free flu vaccine available. (

FDA has approved the combined use of Janssen’s simprevir (Olysio) with Gilead’s sofosbuvir (Sovaldi) to treat hepatitis C genotype 1, making the pair the second all-oral treatment for this condition. FDA approved the combination for a standard 12 weeks of therapy if patients don’t have cirrhosis and 24 weeks if they do. A full course (12 weeks) of sofosbuvir costs $84,000. A full course of simeprevir costs $66,000. (

FDA has approved Roche’s bevacizumab (Avastin) to be used in combination with chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan chemotherapy) for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received no more than two prior chemotherapy regimens. Bevacizumab has already been approved to treat cancers of the lungs, colon, cervix, kidneys, and brain (glioblastoma). Avastin carries boxed warnings for GI perforation, complications connected with surgery and wound healing, and hemorrhage. (

Janssen announced FDA approval, under priority review, of its supplemental new drug applications for use of paliperidone palmitate (Invega Sustenna), a once-monthly atypical long-acting antipsychotic, as an adjunctive or monotherapy to treat schizoaffective disorder. A boxed warning notes risk of increased mortality in elderly patients with dementia-related psychosis. (

Eli Lilly announced that ramucirumab (Cyramza) has been approved for use in combination with paclitaxel for second-line advanced gastric cancer after previous chemotherapy containing fluoropyrimidine or platinum has been tried. A boxed warning notes increased risk of hemorrhage. (

FDA has approved Regeneron’s aflibercept injection (Eylea) to treat macular edema following retinal vein occlusion (RVO). Aflibercept is already approved to treat wet age-related macular degeneration, diabetic macular edema, and macular edema following CRVO. (

New generics

Heritage Pharmaceuticals has launched felodipine extended-release tablets in strengths of 2.5 mg, 5 mg, and 10 mg. Indicated to treat hypertension, felodipine is the AB-rated generic equivalent to Plendil, AstraZeneca’s calcium channel blocker. (

Also available from Heritage is sterile rifampin for injection USP, 600 mg/vial, the AP-rated generic equivalent to Rifadin IV, the Sanofi Aventis antibiotic drug, indicated to treat all forms of tuberculosis. (

Amneal has announced the launch of estradiol/norethindrone acetate tablets (Lopreeza) in strengths of 0.5 mg/0.1 mg and 1 mg/0.5 mg, the first authorized generic equivalent to Novo Nordisk’s Activella, indicated to treat post-menopausal symptoms. Both strengths are now shipping. (

Dr. Reddy’s recently launched docetaxel injection USP, 20 mg/1 mL and 80 mg/4 mL, a therapeutically equivalent generic version of Taxotere (Sanofi Aventis), used to treat locally advanced or metastatic breast cancer after failure of previous chemotherapy. A boxed warning cites risk of toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention. (

Dr. Reddy’s has also launched sirolimus tablets  in 1-mg and 2-mg strengths, a therapeutically equivalent generic version of Wyeth’s Rapamune. It is indicated to prevent kidney rejection in renal transplant patients 13 years of age and older. A boxed warning states that its use is not recommended for liver or lung transplant patients. (

FDA has granted approval to both Dr. Reddy’s and Endo International for their generic versions of Genentech’s antiviral valganciclovir tablets USP, (Valcyte), 450 mg. Ranbaxy lost the opportunity to launch the first generic version of Valcyte after quality control issues at its Indian production facilities led to a ban on Ranbaxy exports to the United States. ( (

Perrigo recently announced that it has agreed to market tacrolimus ointment, the authorized generic version of Protopic ointment 0.1% and 0.03% from Astellas U.S., indicated to treat moderate-to-severe eczema. (

Teva has launched dexmethylphenidate hydrochloride extended-release capsules, CII, 5 mg, the AB-rated bioequivalent to Novartis’ Focalin XR extended-release capsules, CII, used to treat attention deficit hyperactivity disorder in patients six years of age and older. Teva also offers this product in strengths of 15 mg, 30 mg, and 40 mg. (

Mylan has launched lamivudine/zidovudine tablets USP, 150 mg/300 mg, its generic version of Combivir from Viiv Healthcare, indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. A boxed warning cites a range of possible reactions. (



Dr. Reddy’s has announced the U.S. launch of fexofenadine hydrochloride 60 mg/pseudoephedrine hydrochloride 120 mgextended-release tablets, a bioequivalent generic version of Allegra-D 12 Hour Allergy and Congestion (Chattem/Sanofi Aventis), indicated for relief of symptoms of indoor and outdoor allergies, such as congestion, sinus pressure, runny nose, sneezing, and itchy eyes and nose. (

Seasonal travelers seeking relief from symptoms of jet lag such as fatigue, insomnia, and anxiety can now opt for JetRyte Effervescent Tablets, formulated with sodium, potassium, vitamins B6, B12, and C, magnesium, and melatonin to replenish key nutrients lost through dehydration. The citrus-flavored tablets dissolve in any water bottle within two minutes. (

Dermend Alpha+Beta Hydroxy Therapy is a thick, rich moisturizer available as both a lotion and a cream from Dermend Moisturizing Bruise Formula. It is formulated with glycolic and salicylic acids to exfoliate and soothe severely dry, flaky skin. Products should be used with sunscreen and sun exposure should be limited. (

Zicam has launched two new homeopathic products for the winter season: Zicam Cold Remedy Nasal Spray for adults and Zicam Kids, a zinc-based grape-flavored soft chew for children from six to 11 years of age. (

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