New products for pharmacists 07-10-2014

NEW DRUGS

New Rx

Image courtesy of Cubist PharmaceuticalsIn June, Cubist Pharmaceuticals announced FDA approval of tedizolid phosphate (Sivextro) to treat Gram-positive adult acute bacterial skin and skin structure infections (ABSSSI). The once-daily, six-day oral therapy is the second recently approved medication to offer an alternative to IV therapy for patients with methicillin-resistant Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, and Enterococccus faecalis, following FDA’s approval of dalbavancin in May. Common adverse reactions for Sivextro include nausea, headache, diarrhea, vomiting, and dizziness. Patients may be eligible for assistance from AccessSIVEXTRO, a co-pay program created by the company. (www.sivextro.com)

Image courtesy of Biogen IdecAlso in June, FDA approved Biogen Idec’s antihemophilic factor (recombinant), Fc fusion protein (Eloctate), for use by adults and children with hemophilia A. Identified by the company as “the first and only factor VIII with a prolonged half-life,” the product is the first hemophilia A treatment to require less frequent injections when used to prevent or reduce the frequency of bleeding. Allergic reactions may include breathing difficulties, tightness in the chest, facial swelling, rash, or hives. FDA has given this product orphan drug status. (www.eloctate.com)

FDA has approved Valeant’s efinaconazole 10% topical solution (Jublia), which the company calls “the first topical triazole approved for the treatment of onychomycosis of the toenails.” This common fungal nail infection is often undertreated owing to lack of treatment options. According to the company, OTC products have limited effectiveness, and safety concerns limit use of Rx oral treatments. The product is applied to the nail daily from a bottle/brush device; there are no safety issues. (www.valeant.com)

Strativa has announced FDA approval of its prescription vitamin B12 supplement (Nascobal nasal spray), indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission after intramuscular vitamin B12 therapy and who have no nervous system involvement. One spray, in one nostril, once a week, delivers 500 µg of cyanocobalamin, USP. (www.nascobal.com)

Upsher-Smith has granted Sandoz exclusive U.S. distribution rights for Klor-Con, its line of branded potassium chloride products. Potassium chloride is used to prevent or treat low levels of potassium in the blood (hypokalemia). Marketing under the Sandoz name commenced July 1. (www.sandoz.com)

New generics

In June, Lannett Co. received FDA approval for codeine sulfate tablets USP, a schedule II controlled substance used to treat mild-to-moderate pain, in 15-mg, 30-mg, and 60-mg dosage strengths. This product is the equivalent to Roxane Labs’ codeine sulfate tablets USP 15 mg, 30 mg, and 60 mg. (www.lannett.com)

Mylan has launched risedronate sodium tablets USP, 150 mg, the generic version of Warner Chilcott’s Actonel tablets. A company statement indicates that risedronate, a bisphosphonate, is  used to treat or prevent osteoporosis in postmenopausal women. (www.mylan.com)

Teva has announced the introduction and availability of its estradiol and norethindrone acetate tablets, USP (Mimvey Lo), an AB-rated product that is the bioequivalent of Activella tablets, used by women after menopause to reduce moderate-to-severe hot flushes, treat moderate-to-severe physiological changes, and help reduce the risk of osteoporosis. (www.tevagenerics.com)

Teva also has received FDA approval to market celecoxib capsules in 50-mg, 100-mg, 200-mg, and 400-mg strengths, and won 180-day exclusivity on the latter three products. A treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions, celecoxib is the generic equivalent of Pfizer’s Celebrex. (www.tevagenerics.com)

FDA also has granted approval to Mylan to market celecoxib capsules in the 50-mg formulation. (www.mylan.com)

OTC

Image courtesy of Klean AthleteThe nutritional supplement line Klean Athlete has launched Klean Recovery, a carbohydrate-protein mix designed to support muscle recovery after exercise. The milk-chocolate protein powder contains a combination of whey protein isolate and a hydrolyzed marine protein said to be easily digested and quickly absorbed, as well as amino acids such as methionine, histidine, and arginine. This product is NSF-certified for sport, meaning that it has been found free of banned substances. (www.kleanathlete.com)

Nutritional supplement-maker Pure Encapsulations has launched Pure Biome, a new line of freeze-dried probiotics. Each of its four formulas includes a blend of four probiotic strains designed to support specific physical conditions. According to a company statement, freeze-drying enables probiotics to maintain potency when combined with active ingredients that might otherwise compromise their effectiveness. (www.pureencapsulations.com/PureBiome)

Image courtesy of Pure Encapsulations

In April, Gaia Herbs announced the launch of Turmeric Supreme: Allergy, a combination of herbal extracts designed to “support a healthy response to allergens.” The product combines turmeric with other ingredients such as black pepper extract, said to increase the qualities of absorption and bioavailability of the curcumins found in turmeric, whichreduce inflammation. It also includes quercetin, a flavonoid derived from plants, which is said to normalize histamine levels and regulate overall bodily inflammation. (www.gaiaherbs.com)

Image courtesy of Gaia Herbs

NEW DEVICES

Image courtesy of Novo NordiskNew from Novo Nordisk for insulin-dependent diabetics is Insulin detemir [rDNA origin] injection (Levemir FlexTouch), a prefilled insulin delivery device designed to prevent push-button extension when a dose is dialed. With 300 units of detemir insulin that can be dosed in 1-unit increments up to 80 units, the pen can be used with with NovoFine and NovoTwist needles. A company spokesman stated that “the reduced reach and low injection-force button are both advancements.” Needles are sold separately and may require a prescription. (www.levemirpro.com)

Jant Pharmacal has announced the launch of the LipidPlus Professional Lipid Profile and Glucose Measuring System, a group of products for point-of-care testing of total cholesterol, high- and low-density lipoprotein, triglycerides, and blood glucose. The system includes lipid and glucose test strips; an analyzer and a printer, both battery-operated and hand-held; and glucose- and lipid-profile controls. For ordering information or to locate a distributor, go to www.lipidplus.com.