New Products for Pharmacists

May 10, 2014

New Rx, new generics, and new OTC

New Rx

FDA has approved naloxone hydrochloride injection (Evzio; Kaleo, Inc.), the first hand-held auto-injector to reverse opioid overdose that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. The product delivers a single dose of the drug naloxone by means of a device that can be carried in a pocket or stored in a medicine cabinet. The product is sold with a trainer device, enabling the family member or caregiver to practice administration in advance of need. (http://www.evzio.com)

 

Aptiom (Image courtesy of Sunovion)

 

Sunovion has announced that eslicarbazepine acetate (Aptiom), an antiepileptic used as adjunctive treatment for partial-onset seizures, is now available in U.S. pharmacies in 200-mg, 400-mg, 600-mg and 800-mg dosages. It can be taken whole or crushed, with or without food. (www.sunovion.com)

Alprolix (Image courtesy of Biogen Idec)

 

 

 

FDA has approved Biogen Idec’s Coagulation Factor IX (Recombinant), Fc Fusion Protein, (Alprolix), for treatment of adults and children with hemophilia B. The company says that the product is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. (http://www.biogenidec.com)

 

 

 

Tretten (Image courtesy of Novo Nordisk)

 

Novo Nordisk has announced the U.S. availability of Coagulation Factor XIII A-Subunit [Recombinant] (Tretten), used for the routine prophylaxis of bleeding in people with congenital factor XIII (FXIII) A-subunit deficiency, which is a serious, rare bleeding disorder with limited treatment options. The company states that this product is the only recombinant treatment for this condition. (www.novonordisk.com/)

 

 

FDA recently approved Oralair, a product from Stallergenes S.A., that combines freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy, to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After the first dose is administered by the healthcare provider and the patient observed for potential adverse reactions, subsequent doses can be taken at home. Because of the potential for severe allergic reactions, the prescribing information includes a boxed warning and there is a Medication Guide for patients. (www.stallergenes.com)

FDA has approved Merck, Sharp & Dohme’s Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age. Treatment with the once-daily Ragwitek tablet begins 12 weeks before the start of ragweed pollen season and continues throughout the season. A healthcare provider administers the first dose and observes the patient for 30 minutes. Subsequent doses may be taken by the patient at home. Because severe allergic reaction is possible, the product has a boxed warning and a companion Medication Guide. (http://bit.ly/ragwitekpi)

FDA has also approved Merck’s Timothy Grass pollen allergen extract tablet for sublingual use (Grastek) for the treatment of Timothy grass pollen-induced allergic rhinitis, with or without conjunctivitis, in individuals aged 5 to 65 years, with the understanding that autoinjected epinephrine will be available to patients at home. The product includes a boxed warning that it may not be appropriate for those with severe or unstable asthma. (http://bit.ly/grastekpi)

   

New Generics

Amlodipine besylate/atorvastatin calcium (Image courtesy of Greenstone LLC)Pfizer subsidiary Greenstone LLC has launched amlodipine besylate/atorvastatin calcium tablet, an authorized generic of Pfizer’s Caduet, in numerous dosage strengths. Caduet is used to treat hypertension and angina, and to reduce risk of stroke and heart attack in vulnerable patient populations. (http://www.greenstonellc.com/product-list.aspx)

 

 

Omega-3-acid ethyl esters capsules USP (Image courtesy of Teva)

 


Teva has announced FDA approval of its omega-3-acid ethyl esters capsules, USP, the AB-rated generic equivalent to GlaxoSmithKline’s Lovaza capsules. This product is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Teva believes it is first-to-file and thus far is the only company to receive an approval from FDA for this product. Teva plans to commence shipping immediately. (http://www.tevagenerics.com)

 

 

FDA also has approved Teva’s raloxifene HCl tablets, 60 mg, the generic equivalent to Eli Lilly’s Evista tablets. As the first company to file, Teva is eligible for 180 days of marketing exclusivity and has begun shipping the product. (http://www.tevagenerics.com)

 

Eszopiclone tablets (C-IV) (Image courtesy of Teva)Teva also has launched eszopiclone tablets (C-IV), 1, 2, and 3 mg, its generic equivalent of Sunovion’s Lunesta tablets, used to treat insomnia. (http://www.tevagenerics.com)

 

On April 15, Dr. Reddy’s launched its Lunesta equivalent, eszopiclone (C-IV), in 1-mg, 2-mg and 3-mg tablets. (http://www.drreddys.com)

 

Dr. Reddy’s also has launched its fenofibrate capsules, capsules (43 mg and 130 mg), a generic equivalent of Lupin's Antara capsules, in the United States. Fenofibrate is indicated to reduce cholesterol and triglyceride levels in the blood and help mitigate the risk of atherosclerosis. (http://www.drreddys.com)

 

FDA has approved Lupin’s pioglitazone tablets, generic versions of Takeda’s Actos, in 15-mg, 30-mg, and 45-mg dosage strengths. Pioglitazone is used in conjunction with diet and exercise to manage type 2 diabetes in adults. (http://www.lupinpharmaceuticals.com)

 

Amneal has announced FDA approval of its ANDA for atovaquone oral suspension USP, 750-mg/5-mL, the generic equivalent of GlaxoSmithKline's Mepron. Mepron is used to prevent Pneumocystis jiroveci pneumonia, a fungal infection of the lungs, in patients who cannot tolerate trimethoprim-sulfamethoxazole. (http://amneal.com)

 

Sandoz has launched its calcipotriene and betamethasone dipropionate ointment in 60-g and 100-g tubes. This is the first generic version of Leo Pharma’s Taclonex Ointment, a combination of a vitamin D analog and a corticosteroid indicated for the topical treatment of psoriasis in adults. Sandoz will market the product in partnership with Tolmar Inc., owner of the ANDA and recipient of FDA’s first approval for this generic product. (www.sandoz.com)

NEW OTC

Bacteril (Image courtesy of Europharma)

 

Europharma has announced the launch of Bacteril, an immune support product that combines high concentrations of the oils of cinnamon, thyme, clove, and oregano. According to the company, botanical oils can be up to 100 times more concentrated than dry plan extracts. Bacteril is now available under the Terry Naturally brand and can be found in integrative pharmacies nationwide. (ww.EuropharmaUSA.com)