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Weekly Drug News Round Up - March 12, 2014

First TENS Device Approved to Prevent Migraines

The cost of the device in the United States is not known yet, but it sells for about US $314 in Canada Read More...

The U.S. Food and Drug Administration (FDA) has approved a new device aimed at preventing debilitating migraine headaches. The device, called Cefaly, is the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain. Cefaly, distributed by Canadian company Roxon, is a battery-powered, prescription device that resembles a plastic headband worn across the forehead. Cefaly works by stimulating branches of the trigeminal nerve and is considered an alternative to oral migraine medications like the triptans, as noted by the FDA. It should only be used 20 minutes per day. The device has been shown to reduce to the number of migraine days per month and lower migraine medication use compared to a placebo device.

Endo’s Aveed FDA-Approved for Testosterone Replacement

Endo announced Aveed is expected to be available in early March Read More...

Endo Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval of Aveed (testosterone undecanoate), a long-acting depot injection for the treatment of male hypogonadism (Low-T). The approval of Aveed, an androgen steroid, is based on data from an 84-week Phase 3 trial of hypogonadal men. Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL. Aveed increased mean serum testosterone levels and they were maintained for up to 10 weeks. Aveed is given by intramuscular injection once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter.

FDA Updates Doribax Label Based on Unapproved Use

Doribax, an antibacterial drug, is not approved to treat any type of pneumonia Read More...

The U.S. Food and Drug Administration (FDA) is updating the Doribax (doripenem) label to outline an increased risk of death and lower clinical cure rates compared to use of imipenem-cilastatin for injection (Primaxin) in patients with ventilator-associated bacterial pneumonia. In a clinical trial that was stopped early, the 28-day all-cause mortality was higher in the Doribax arm (23.0%; n=31/135) than in the imipenem and cilastatin arm (16.7%; n=22/132). Doribax is still safe and effective for its FDA-approved indications - treatment of complicated intra-abdominal infections and complicated urinary tract infections.

Effexor XR, Venlafaxine Recall Due to Possible Mix-Up With Tikosyn

Pharmacists should immediately return all recalled lots and notify patients to whom they distributed the products Read More...

Pfizer Inc. has issued a voluntary recall of an antidepressant -- one lot of Effexor XR (venlafaxine HCl) 150 mg, one lot of Effexor XR (venlafaxine HCl) 150 mg, and one lot of venlafaxine HCl 150 mg extended-release (Greenstone). A pharmacist reported that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn (dofetilide) 0.25mg, a heart rhythm control drug, in addition to the Effexor XR capsules. The use of dofetilide with venlafaxine could result in serious or fatal contraindications or drug interactions. This recall involves Pfizer lot numbers V130142, V130140 and Greenstone lot number V130014.

Teva Announces Approval of Generic Evista for Osteoporosis

Teva reports they will begin shipping the product within the next 30 days Read More...

Teva Pharmaceutical announced the approval of the generic equivalent to Evista (raloxifene) tablets, 60 mg, in the United States. Teva was the first manufacturer to file with the U.S. Food and Drug Administration (FDA), making the product eligible for 180 days of marketing exclusivity. Raloxifene is used in osteoporosis prevention and treatment and for breast cancer prevention. Eli Lilly's Evista had US sales of $824 million in 2013. Many other first time brand-to-generic switches will occur in 2014 resulting in significant savings in health care dollars.

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