Magazine article Drug Topics

New Products

Magazine article Drug Topics

New Products

Article excerpt

RX&OTC

RX CARE

New drugs

In June, Cubist Pharmaceuticals announced FDA approval of tedizolid phosphate (Sivextro) [1] to treat Grampositive 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 methidllin-resistant Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, and Enterococccusfaecalis, following FDA's approval of dalbavandn 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)

Also in June, FDA approved Biogen IdeUs antihemophilic factor (recombinant), Fc fusion protein (Eloctate) [2], 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 pg of cyanocobalamin, USP. (wwwjiascobal.com)

Upsher-Smith has granted Sandoz exclusive U.S. distribution rights for KlorCon, 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. (wwwsandoz.com)

New generics

In June, Lannett Co. received FDA approval for codeine sulfate tablets USP, a schedule n 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. (wwwJannett.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, (wwwmylan.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-tosevere hot flushes, treat moderate-tosevere physiological changes, and help reduce the risk of osteoporosis, (www. …

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