New brand drugs, generics, and over-the-couter products.
The FDA has approved Voluven, manufactured by German company Fresenius Kabi, http://www.fresenius-kabi.com/. The new intravenous product contains 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection and is indicated for restoring blood volume following surgery. The synthetic starch molecules contained in the product do not dissolve in water and are linked together and combined with a salt solution in a concentration similar to human blood. The drug is not indicated for patients on dialysis or with kidney failure, bleeding inside the head, severe increases in blood levels of sodium chloride, or known sensitivity to the synthetic starch in the drug.
CSL Behring, http://www.cslbehring.com/, has begun offering Helixate FS, its advanced recombinant FVIII (rFVIII) factor product for the treatment of hemophilia A, in a 2000IU vial. According to the company, the new vial size offers shorter infusion time and is packaged with Mix2Vial, its needle-free transfer device.
Glumetza (metformin hydrochloride extended-release tablet) is now available from Depomed, http://www.glumetzaxr.com/, in a 1000-mg tablet. It offers once-daily oral dosing for adults with Type 2 diabetes. The tablets, manufactured by King, utilize Depomed's AcuForm drug delivery technology to provide controlled and prolonged release of metformin. The drug is indicated for use alone or in combination with sulfonylurea or insulin as an adjunct to diet and exercise for improved glycemic control.
Shire USA has received approval to offer three new dosage strengths for its attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate). Vyvanse, http://www.vyvanse.com/, is therapeutically inactive until metabolized in the body and will now be available in 20-, 40-, and 60-mg dosage strengths for once-daily dosing. The medication was formulated to provide lower potential for abuse. The FDA has proposed that Vyvanse be classified as a Schedule II controlled substance.
Desonate (desonide gel) 0.05% 120-g, the non-irritating treatment for mild to moderate eczema from SkinMedica, http://www.skinmedica.com/, is now available in a twin package, free from potentially drying alcohol, fragrance, or surfactants. The product can be used in children over three months of age and for adults with the chronic itching and inflammatory symptoms of atopic dermatitis. The new packaging contains two 60-g tubes of the gel.